Identity
- Trade Name
- Synergy CT PICC EUDAMEDSynergy FDA UDI
- Generic Name
- Peripherally-inserted central venous catheter FDA UDI
- Device Name
- PICC Procedure Pack EUDAMED5Fr x 60cm Single Lumen Synergy CT PICC Basic Kit FDA UDI
- Model / Reference
- A14-05160 EUDAMEDFDA UDI
- Description
- 5Fr x 60cm Single Lumen Synergy CT PICC Basic Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00876604001107 EUDAMEDFDA UDI
- Basic UDI-DI
- 087660400PP-PICC01001N8 EUDAMED
- 510(k) Number
- K101329 FDA UDI
- FDA Product Code
- LJS FDA UDI
- EMDN Code
- C010102 PERIPHERAL I.V. CATHETER SYSTEMS EUDAMED
- GMDN Term
- Peripherally-inserted central venous catheter FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5970 FDA UDI
- Medical Purpose
- The intended purpose of the PICC Procedure Pack is to provide convenience accessories to assist vascular professionals and physicians in attaining the surgical insertion of peripherally central venous catheters. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA 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
Synergy CT PICC by Health Line International Corp — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: SYNERGY CT PICC™ Line Max Barrier Kit
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 087660400PP-PICC01001N8 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Health Line International Corp
- EUDAMED SRN
- US-PR-000013766
Sources (2)
- EUDAMED 9ca6c106-36fe-4751-8f5f-e9166c858166 61 fields · synced Jun 17, 2026
- FDA UDI 5b28ab2c-d2e4-40aa-8835-3880d1ba384a 34 fields · synced May 30, 2026