Identity
- Trade Name
- Synergy FDA UDI
- Generic Name
- Peripherally-inserted central venous catheter FDA UDI
- Device Name
- 5F x 60 cm Single Lumen Synergy CT PICC IR Kit FDA UDI
- Model / Reference
- A14-05160-IR-03 FDA UDI
- Description
- 5F x 60 cm Single Lumen Synergy CT PICC IR Kit FDA UDI
Identifiers
- Catalog Number
- A14-05160-IR FDA UDI
- Primary DI / UDI-DI
- 00876604004771 FDA UDI
- 510(k) Number
- K101329 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- Peripherally-inserted central venous catheter 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
Yes
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
Category: Peripherally-inserted central venous catheter
Synergy by Health Line International Corp — 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
- BioFlo — NAVILYST MEDICAL, INC. · Class II
Cleared under the same submission
K101329 also covers:
- Synergy — Health Line International Corp
- Synergy — Health Line International Corp
- Synergy — Health Line International Corp
- Synergy — Health Line International Corp
- Synergy — Health Line International Corp
- Synergy — Health Line International Corp
- Synergy — Health Line International Corp
- Synergy — Health Line International Corp
- Synergy — Health Line International Corp
- Synergy — Health Line International Corp
- Synergy — Health Line International Corp
- Synergy — Health Line International Corp
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
- Health Line International Corp
Sources (1)
- FDA UDI 45f6a341-c88e-4624-9b21-653c085d7c0a 35 fields · synced May 30, 2026