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Resuscitation Face Mask Single Use Anatomical with Pre-Inflated Cushion Neonatal NF-170-10U

by Flexicare Medical Limited

Listed FDA GUDID listing, not in commercial distribution

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 Number00854401006600 UDI-DI Date30 Oct 2019ListedStatusListed GUDID: not 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  • Withdrawn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
Resuscitation Face Mask Single Use Anatomical with Pre-Inflated Cushion Neonatal
Generic Name
Cardiopulmonary resuscitation mask, single-use
Model / Reference
NF-170-10U
Primary DI / UDI-DI
00854401006600
FDA Product Code
BYG
GMDN Term
Cardiopulmonary resuscitation mask, single-use
Device Class
Class I
Regulation Number
868.5580
GUDID distribution status
Not in Commercial Distribution

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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