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MEDRAD® Twist & Go Sterile High Pressure Connector Tubing. 120cm (48in)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing. 120cm (48in) FDA UDI
- Generic Name
- Radiographic procedure tubing FDA UDI
- Device Name
- ASSY,TBG,TWIST-GO,48”,UV,MC,WLD (86566796) FDA UDI
- Model / Reference
- TAG C120 HPCT FDA UDI
- Description
- ASSY,TBG,TWIST-GO,48”,UV,MC,WLD (86566796) FDA UDI
Identifiers
- Catalog Number
- TAG C120 HPCT FDA UDI
- Primary DI / UDI-DI
- 00616258021515 FDA UDI
- 510(k) Number
- K131517 FDA UDI
- FDA Product Code
- FPK FDA UDI
- GMDN Term
- Radiographic procedure tubing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
MEDRAD® Twist & Go Sterile High Pressure Connector Tubing. 120cm (48in) 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
K131517 also covers:
- MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 120cm (48in) — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 120cm (48in) — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 120cm (48in) — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) — 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 db52fa1b-ad43-4e4d-833d-50024741b6f9 36 fields · synced Jun 9, 2026