FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe & QFT
DI: 00616258011004
·
Model: 200-FT-Q
·
BAYER MEDICAL CARE INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe & QFT
- Primary DI
- 00616258011004
- Version / Model
- 200-FT-Q
- Catalog Number
- 200-FT-Q
- Company Name
- BAYER MEDICAL CARE INC.
- Labeler DUNS
- 058716649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-02
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3e5f41c6-be49-4a1f-9192-75956fc073a9
Device Description
200 ML FasTurn Syringe with Quick Fill Tube (ASSY,PKG,SYR,200ML W/QFT,ODYSSEY,RU,MC) (85687263)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15286 | Angiographic syringe | A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40616258011002 | GS1 | 50 | In Commercial Distribution | 9999-12-31 | |
| Primary | 00616258011004 | GS1 |
Customer Contacts
- Phone
- +1(800)633-7231
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K822536 | 000 |