Identity
- Trade Name
- HydroPICC Dual Lumen FDA UDI
- Generic Name
- General surgical procedure kit, medicated FDA UDI
- Device Name
- 5F Dual Lumen Peripherally Inserted Central Marked Catheter (Mobile Kit) FDA UDI
- Model / Reference
- 90002104 FDA UDI
- Description
- 5F Dual Lumen Peripherally Inserted Central Marked Catheter (Mobile Kit) FDA UDI
Identifiers
- Catalog Number
- 90002104 FDA UDI
- Primary DI / UDI-DI
- 00850030354402 FDA UDI
- 510(k) Number
- K213550 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- General surgical procedure kit, medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5970 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
No
FDA UDI
MR Conditional FDA UDI
Category: General surgical procedure kit, medicatedPeripherally-inserted central venous catheter
HydroPICC Dual Lumen by Access Vascular, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripherally-inserted central venous catheter.
- BioFlo — NAVILYST MEDICAL, INC. · Class II
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- ARROW — TELEFLEX INCORPORATED · Class II
- PowerPICC — Bard Access Systems, Inc. · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- PowerPICC Provena — Bard Access Systems, Inc. · Class II
- BioFlo — NAVILYST MEDICAL, INC. · Class II
Cleared under the same submission
K213550 also covers:
- HydroPICC Catheter — ACCESS VASCULAR, INC
- HydroPICC Dual Lumen — ACCESS VASCULAR, INC
- HydroPICC Dual Lumen — ACCESS VASCULAR, INC
- HydroPICC Dual Lumen — ACCESS VASCULAR, INC
- HydroPICC Dual Lumen — ACCESS VASCULAR, INC
- HydroPICC Dual Lumen — ACCESS VASCULAR, INC
- HydroPICC Dual Lumen — ACCESS VASCULAR, INC
- HydroPICC Dual Lumen — ACCESS VASCULAR, INC
- HydroPICC Dual Lumen — ACCESS VASCULAR, INC
- HydroPICC Dual Lumen — ACCESS VASCULAR, 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 |
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Manufacturer
- Manufacturer
- Access Vascular, Inc
Sources (1)
- FDA UDI f401c812-a2ad-461a-9810-8691d1a2c09c 35 fields · synced Jun 6, 2026