Identity
- Trade Name
- Disposable MRI Kit with Check Valve FDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Device Name
- Spectris MR Injector Kit (Includes: (2) 65 ML Front Load syringes, 96" low pressure tubing with an integrated check valve, 1 large spike for loading saline, 1 small spike (KIT,SYR/SPIKE/T,65mL FLS,MRI,MC,CH) (60728559) FDA UDI
- Model / Reference
- SQK 65VS FDA UDI
- Description
- Spectris MR Injector Kit (Includes: (2) 65 ML Front Load syringes, 96" low pressure tubing with an integrated check valve, 1 large spike for loading saline, 1 small spike (KIT,SYR/SPIKE/T,65mL FLS,MRI,MC,CH) (60728559) FDA UDI
Identifiers
- Catalog Number
- SQK 65VS FDA UDI
- Primary DI / UDI-DI
- 00616258007779 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 — FDA UDI — listed in FDA GUDID — 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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bayer Medical Care Inc.
Sources (1)
- FDA UDI dd00fe6b-fbfe-4d90-a475-abde97efebea 36 fields · synced Jun 9, 2026