Identity
- Trade Name
- Saline Syringe & Tubing for MR Injector System FDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Device Name
- Saline Syringe & Tubing for MR Injector System (KIT,115ML 96" CT/INT T/CV,MRI, MR,MC) (60728605) FDA UDI
- Model / Reference
- SSQK 115 FDA UDI
- Description
- Saline Syringe & Tubing for MR Injector System (KIT,115ML 96" CT/INT T/CV,MRI, MR,MC) (60728605) FDA UDI
Identifiers
- Catalog Number
- SSQK 115 FDA UDI
- Primary DI / UDI-DI
- 00616258005461 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Angiographic syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Category: Angiographic syringe
Saline Syringe & Tubing for MR Injector System by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Bayer Medical Care Inc.
Sources (1)
- FDA UDI d2c378fe-4fd4-4058-b803-f94b1191e8b3 35 fields · synced Jun 9, 2026