FDA UDI
In Commercial Distribution
🇺🇸 United States
GEM FLOW COUPLER AC POWER SUPPLY KIT, US
DI: 00844735006155
·
Model: GEM1020PS-2
·
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GEM FLOW COUPLER AC POWER SUPPLY KIT, US
- Primary DI
- 00844735006155
- Version / Model
- GEM1020PS-2
- Catalog Number
- 515600001011
- Company Name
- SYNOVIS MICRO COMPANIES ALLIANCE, INC
- Labeler DUNS
- 031284586
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-30
- Public Version
- 6
- Public Version Date
- 2023-07-21
- Public Version Status
- Update
- Public Device Record Key
- 09fefaa1-c016-44d6-903b-9ca34540886d
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DPW | FLOWMETER, BLOOD, CARDIOVASCULAR | Cardiovascular | 870.2100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45804 | Electrical mains power cable | An insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00844735006155 | GS1 |
Customer Contacts
- Phone
- +1(800)510-3318
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191252 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius