Low Pressure Connector Tubing Integral “T” with Check Valve
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MEDRAD® Stellant Syringe Kits EUDAMEDLow Pressure Connector Tubing Integral “T” with Check Valve FDA UDI
- Generic Name
- Radiographic procedure tubing FDA UDI
- Device Name
- MEDRAD® Stellant Syringe Kits EUDAMEDASSY,TBG,SNGL,LPCT,T-CONN,CV,MC,CORE (87622649) FDA UDI
- Model / Reference
- LP-96-T-CV EUDAMEDFDA UDI
- Description
- ASSY,TBG,SNGL,LPCT,T-CONN,CV,MC,CORE (87622649) FDA UDI
Identifiers
- Catalog Number
- LP-96-T-CV FDA UDI
- Primary DI / UDI-DI
- 00616258024431 EUDAMEDFDA UDI
- Basic UDI-DI
- 0616258TFCN-0050Q5 EUDAMED
- 510(k) Number
- K023183 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES EUDAMED
- GMDN Term
- Radiographic procedure tubing FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Radiographic procedure tubing
Low Pressure Connector Tubing Integral “T” with Check Valve by Bayer Medical Care Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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
K023183 also covers:
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
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Manufacturer
- Manufacturer
- Bayer Medical Care Inc.
Sources (2)
- FDA UDI 9bfe8bdc-d331-48cc-8fc2-e07f99c30ea3 38 fields · synced Oct 7, 2026
- EUDAMED d1a67472-1355-4ba0-8a9b-a5c085205a3c 61 fields · synced Oct 7, 2026