Identity
- Trade Name
- 10” (25 cm) High Pressure Connector Tube FDA UDI
- Generic Name
- Radiographic procedure tubing FDA UDI
- Device Name
- 10" High Pressure Connector Tube with fixed hub (TUBING, 10" CONNECTOR #82011102, MC) (85029037) FDA UDI
- Model / Reference
- DCT 100 FDA UDI
- Description
- 10" High Pressure Connector Tube with fixed hub (TUBING, 10" CONNECTOR #82011102, MC) (85029037) FDA UDI
Identifiers
- Catalog Number
- DCT 100 FDA UDI
- Primary DI / UDI-DI
- 00616258008530 FDA UDI
- 510(k) Number
- K810924 FDA UDI
- FDA Product Code
- DWE FDA UDI
- GMDN Term
- Radiographic procedure tubing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4390 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
10” (25 cm) High Pressure Connector Tube by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radiographic procedure tubing.
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- 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
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 |
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Manufacturer
- Manufacturer
- Bayer Medical Care Inc.
Sources (1)
- FDA UDI ab9cbcea-1720-4827-a434-435e28c18592 36 fields · synced Jun 9, 2026