FDA UDI
In Commercial Distribution
🇺🇸 United States
MPS Power Cord Keeper
DI: 20634624510290
·
Model: 5001029
·
QUEST MEDICAL INC
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MPS Power Cord Keeper
- Primary DI
- 20634624510290
- Version / Model
- 5001029
- Company Name
- QUEST MEDICAL INC
- Labeler DUNS
- 041810693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-10
- Public Version
- 2
- Public Version Date
- 2019-12-11
- Public Version Status
- Update
- Public Device Record Key
- 5a64ca23-45e6-425e-bc5d-933045caf300
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | Cardiovascular | 870.4240 | 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 |
| 11973 | Cardiopulmonary bypass system heat exchanger, reusable | A device consisting of a heat exchanging system intended to be used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for the purposes of cardiopulmonary bypass intervention or treatment. This device will typically be a module of a cardiopulmonary bypass system whereby it receives thermal transfer fluid at a specific temperature from a system heating/cooling unit. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20634624510290 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041979 | 000 |