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MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector FDA UDI
- Generic Name
- Radiographic procedure tubing FDA UDI
- Device Name
- Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a female-to-female adaptor) for pre-filled syringes (SET,PKG,INTEG T/CV,MRI SIT 96V,RAD,MC,JA) (84194891) FDA UDI
- Model / Reference
- SIT 96V FDA UDI
- Description
- Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a female-to-female adaptor) for pre-filled syringes (SET,PKG,INTEG T/CV,MRI SIT 96V,RAD,MC,JA) (84194891) FDA UDI
Identifiers
- Catalog Number
- SIT 96V FDA UDI
- Primary DI / UDI-DI
- 00616258007298 FDA UDI
- 510(k) Number
- K980417 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Radiographic procedure tubing 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
No
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: Radiographic procedure tubing
MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Radiographic procedure tubing.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- High Pressure Tubing, Keep™ — Merit Medical Systems, Inc. · Class II
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd. · Class II
- Coeur Acist — Coeur, Inc. · Class II
- Antmed — ShenZhen Antmed Co., Ltd · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Solution Transfer Device — Bracco Diagnostics Inc. · Class II
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.
- 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.
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 cbb56d70-c648-453a-b6c0-bfbfe6fdd7cd 36 fields · synced Jun 9, 2026