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Large Nasal Pillows System 8013

by Remsleep Holdings Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850068303113 UDI-DI Date15 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Large Nasal Pillows System
Generic Name
CPAP/BPAP nasal mask, reusable
Model / Reference
8013
Primary DI / UDI-DI
00850068303113
510(k) Number
FDA Product Code
BZD
GMDN Term
CPAP/BPAP nasal mask, reusable
Device Class
Class II
Regulation Number
868.5905
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K233415)

Show all (12)

Other devices from Remsleep Holdings Inc

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No