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NeuRx DPS™ System Kit, Canada

FDA UDI

Class III (US FDA UDI)

by Synapse Biomedical, Inc.

Identity

Trade Name
NeuRx DPS™ System Kit, Canada FDA UDI
Generic Name
Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator FDA UDI
Model / Reference
20-0032 FDA UDI

Identifiers

Primary DI / UDI-DI
00852184003243 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

NeuRx DPS™ System Kit, Canada 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.

Manufacturer's product page: NeuRx DPS®

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 def940ae-5697-4578-99d2-cfcb94c8aa28 32 fields · synced Jun 8, 2026