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External Pulse Generator

FDA UDI

Class III (US FDA UDI)

by Synapse Biomedical, Inc.

Identity

Trade Name
External Pulse Generator FDA UDI
Generic Name
Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator FDA UDI
Model / Reference
23-0001 FDA UDI

Identifiers

Primary DI / UDI-DI
00852184003502 FDA UDI
FDA Product Code
OIR FDA UDI
GMDN Term
Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator

External Pulse Generator by Synapse Biomedical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synapse Biomedical, Inc.

Sources (1)

  • FDA UDI 513b859e-a8bb-43a4-8110-d25ec4029ced 32 fields · synced May 30, 2026