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MiniMe 2 Pediatric Nasal Vented Mask, Large 60221

by Sleepnet Corporation 2 variants

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

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 Number00814747024782 UDI-DI Date6 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MiniMe 2 Pediatric Nasal Vented Mask, Large
Generic Name
CPAP/BPAP nasal mask, reusable
Model / Reference
60221
Primary DI / UDI-DI
00814747024782
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
MRI Safety
MR Unsafe

From the manufacturer

Manufacturer's product page: MiniMe® Nasal Pediatric Mask Big comfort for small patients

Other devices from Sleepnet Corporation

See all devices from Sleepnet Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • 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