Identity
- Trade Name
- GEM FLOW COUPLER AC POWER SUPPLY KIT, US FDA UDI
- Generic Name
- Electrical mains power cable FDA UDI
- Device Name
- An insulated electrical cord (one piece) designed to connect the Flow COUPLER Monitor to a mains electricity supply socket. It has four adapters to accommodate voltage specific to the EU, UK, US, and Australia. FDA UDI
- Model / Reference
- GEM1020PS-2 FDA UDI
- Description
- An insulated electrical cord (one piece) designed to connect the Flow COUPLER Monitor to a mains electricity supply socket. It has four adapters to accommodate voltage specific to the EU, UK, US, and Australia. FDA UDI
Identifiers
- Catalog Number
- 515600001011 FDA UDI
- Primary DI / UDI-DI
- 00844735006155 FDA UDI
- 510(k) Number
- K191252 FDA UDI
- FDA Product Code
- DPW FDA UDI
- GMDN Term
- Electrical mains power cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2100 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrical mains power cable
Gem Flow Coupler Ac Power Supply Kit, Us by Synovis Micro Companies Alliance, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191252 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Synovis Micro Companies Alliance, Inc
Sources (1)
- FDA UDI 09fefaa1-c016-44d6-903b-9ca34540886d 37 fields · synced Jun 6, 2026