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Avery Breathing Pacemaker System NeurostimulatorTransmitter Digital

by Avery Biomedical Devices, Inc. United States GUDID

Product code GZE

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850252006066 UDI-DIDate8 Nov 2019ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

GUDID · synced 22 Oct 2026

Trade Name
Avery Breathing Pacemaker System
Generic Name
Extramuscular diaphragm/phrenic nerve electrical stimulation system
Model / Ref / Catalog
NeurostimulatorTransmitter Digital, Spirit
Primary DI / UDI-DI
00850252006066
PMA Number
FDA Product Code
GZE
GMDN Term
Extramuscular diaphragm/phrenic nerve electrical stimulation system
Device Class
Class III
Regulation Number
882.5830
Commercial Distribution
In Commercial Distribution

Related devices

Category: Extramuscular diaphragm/phrenic nerve electrical stimulation system

Cleared under the same submission (P860026)

Other devices from Avery Biomedical Devices, Inc.

See all devices from Avery Biomedical Devices, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (9)
  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (1)

  • FDA UDI a09cbc0c-61e1-4e02-bf61-e9b32713de0e 37 fields · synced 22 Oct 2026