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AccuPAP 301-6001

by Engineered Medical Systems, LLC

AccuPAP 301-6001 is a Class II device made by Engineered Medical Systems, LLC, listed in FDA GUDID since 24 Aug 2018 (UDI-DI 00841470107406), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841470107406 UDI-DI Date24 Aug 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
AccuPAP
Generic name
In-line CPAP set, non-nebulizing
Model / reference
301-6001
Primary DI / UDI-DI
00841470107406
FDA product code
BYE
GMDN term
In-line CPAP set, non-nebulizing
Device class
Class II
Regulation number
868.5965
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)