Identity
- Trade Name
- Disposable MRI Kit with Check Valve FDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Device Name
- Spectris MR KIT,SYR/SPIKE/T,65ML FLS,MRI,BURRON and FFA 50 (MR - SPECTRIS SYRINGE KIT, 2-65ML, FFA50) (60728524) FDA UDI
- Model / Reference
- SQK 65VA FDA UDI
- Description
- Spectris MR KIT,SYR/SPIKE/T,65ML FLS,MRI,BURRON and FFA 50 (MR - SPECTRIS SYRINGE KIT, 2-65ML, FFA50) (60728524) FDA UDI
Identifiers
- Catalog Number
- SQK 65VA FDA UDI
- Primary DI / UDI-DI
- 00616258005478 FDA UDI
- 510(k) Number
- K980417 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Angiographic syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 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
Disposable MRI Kit with Check Valve by Bayer Medical Care Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Angiographic syringe.
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Cleared under the same submission
K980417 also covers:
- Disposable MRI Kit A Disposable Kit for use with the 65/65 MR Injector from Baye — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Female - Female Adapter — Bayer Medical Care Inc.
- Female - Female Adapter — Bayer Medical Care Inc.
- Female - Female Adapter — Bayer Medical Care Inc.
- Female - Female Adapter — Bayer Medical Care Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bayer Medical Care Inc.
Sources (2)
- FDA UDI 46a132d2-c5af-45db-8bb6-f0b61a883b6e 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026