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GS27 Bmi GS27

by Bio-Medical Instruments, Ltd.

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 Number00867972000250 UDI-DI Date30 Nov 2016ListedStatusListed 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  • Withdrawn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
GS27
Generic Name
Electrocardiographic electrode, single-use
Model / Reference
BMI GS27
Primary DI / UDI-DI
00867972000250
510(k) Number
FDA Product Code
DRX
GMDN Term
Electrocardiographic electrode, single-use
Device Class
Class II
Regulation Number
870.2360
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiographic electrode, single-use

Other devices from Bio-Medical Instruments, Ltd.

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: 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