Abmrc LLC (manufacturer, Eagan, MN): 1 new FDA device listing, incl. device, positive pressure breathing, intermittent

Abmrc LLC (Eagan, Minnesota): 1 new FDA device listing, incl. device, positive pressure breathing, intermittent. Its amount of 1 is above the median of 1 (50th percentile). Dated 56 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 42 related MN DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentAbmrc LLC
RoleManufacturer
Establishment typesDevelop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198
LocationEagan, MN, US
New listings1
DevicesDevice, Positive Pressure Breathing, Intermittent
Product codesNHJ
Device classesClass II
Medical specialtiesAnesthesiology
Brand namesBiWaze Clear System; BiWaze Two Step Adapter; Coaxial Bacterial Viral Filter; BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Adult Large; BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Adult Small; BiWaze Clear Dual Lumen Breathing Circuit With Face Mask - Child; BiWaze Clear Dual Lumen Breathing Circuit With Trach Adapter; BiWaze Clear Dual Lumen Breathing Circuit - Acute
First new listing2026-09-09
Latest new listing2026-09-09
FDA registration number3016774528
Registration expires2026-12-31
amount percentile50th of 2,570 (median 1, 1.0x median)
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL

  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-09-09
  • Data refreshed: 2026-10-28
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT

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Peer benchmark and outreach value: Abmrc LLC and 43 Minnesota peers

  • Minnesota DeviceEstablishmentPulse records like this one: 43
  • Abmrc LLC's amount: 50th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Minnesota peer: $8,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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70 / 100 Score

  • Brings its own devices to market: buys manufacturing, sterilization and QMS help.
  • Class II or III devices: QMS and regulatory demands.
  • U.S. establishment.

What is the DeviceEstablishmentPulse record for Abmrc LLC in Eagan, Minnesota?

Abmrc LLC (Eagan, MN), a manufacturer, added 1 FDA device listing on 2026-09-09.

How does Abmrc LLC compare to other Minnesota DeviceEstablishmentPulse records?

Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 56 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.

Abmrc LLC vs. top 2 peers

OrganizationLocationAmountPercentileRecord date
Abmrc LLCEagan, MN150th2026-09-09
Piraeus Medical, Inc.Maple Grove, MN483rd2026-10-12
Boston Scientific CorporationSaint Paul, MN2498th2026-10-16

Related records

DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Minnesota

Cross-dataset signals in Minnesota

FdaApprovalPulse: records in Minnesota (61)

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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.

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