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NeoPIP Infant Resuscitator NF-100U

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 Number00854401006389 UDI-DI Date11 Dec 2018ListedStatusListed 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  • Withdrawn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
NeoPIP Infant Resuscitator
Generic Name
Pulmonary resuscitator, pneumatic, reusable
Model / Reference
NF-100U
Primary DI / UDI-DI
00854401006389
FDA Product Code
BTM
GMDN Term
Pulmonary resuscitator, pneumatic, reusable
Device Class
Class II
Regulation Number
868.5915
GUDID distribution status
Not in Commercial Distribution

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Serial Number

Other properties (13)

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