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butterflyBVM READY R300

by Compact Medical, Inc.

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 Number00860012073528 UDI-DI Date3 Oct 2025ListedStatusListed 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  • Withdrawn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
butterflyBVM READY
Generic Name
Pulmonary resuscitator, manual, single-use
Model / Reference
R300
Primary DI / UDI-DI
00860012073528
FDA Product Code
BTM
GMDN Term
Pulmonary resuscitator, manual, single-use
Device Class
Class II
Regulation Number
868.5915
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Other devices from Compact Medical, Inc.

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

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