Mfg One, LLC (contract manufacturer, Chantilly, VA): 6 new FDA device listings, incl. warmer, thermal, infusion fluid

Mfg One, LLC (Chantilly, Virginia): 6 new FDA device listings, incl. warmer, thermal, infusion fluid. Its amount of 6 is above the median of 1 (88th percentile). Dated 119 days ago, it serves as a historical benchmark. Score 80/100. 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: 6 · 88th percentile of 2,570 DeviceEstablishmentPulse records · 6.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 9 related VA DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentMfg One, LLC
RoleContract manufacturer
Establishment typesManufacture Medical Device for Another Party (Contract Manufacturer)
LocationChantilly, VA, US
New listings6
DevicesWarmer, Thermal, Infusion Fluid; Set, Administration, Intravascular; Pump, Infusion
Product codesLGZ, FPA, FRN
Device classesClass II
Medical specialtiesGeneral Hospital
Brand namesThermaCor; TIS 1200; ThermaCor 1200
First new listing2026-07-09
Latest new listing2026-07-09
FDA registration number3004167615
Registration expires2026-12-31
amount percentile88th of 2,570 (median 1, 6.0x 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: 2026-07-09
  • Data refreshed: 2026-10-28
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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: Mfg One, LLC and 10 Virginia peers

  • Virginia DeviceEstablishmentPulse records like this one: 10
  • Mfg One, LLC's amount: 88th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Virginia peer: $2,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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80 / 100 Score

  • Contract manufacturer or sterilizer adding work.
  • Class II or III devices: QMS and regulatory demands.
  • Several new listings at once.
  • U.S. establishment.

What is the DeviceEstablishmentPulse record for Mfg One, LLC in Chantilly, Virginia?

Mfg One, LLC (Chantilly, VA), a contract manufacturer, added 6 FDA device listings on 2026-07-09.

How does Mfg One, LLC compare to other Virginia DeviceEstablishmentPulse records?

Its amount of 6 sits in the upper half (88th percentile) of 2,570 records; the median is 1. It is 119 days old; check the official source for later updates before acting. Its Score of 80/100 puts it among the stronger signals in this feed.

Mfg One, LLC vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Mfg One, LLCChantilly, VA688th2026-07-09
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN483rd2026-10-16
Cook Medical LLCBloomington, IN483rd2026-10-13
Swiss-American CDMO,LLCCarrollton, TX483rd2026-10-12

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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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