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Synergy CT PICC
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref A14-04160-04Ref A14-05160-NRef A14-06260-04Ref A14-05160-04Ref A14-06360-04Ref A14-05260-04
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 Nursing Kit FDA UDI
- Model / Reference
- A14-04160-04 EUDAMEDA14-05160-N EUDAMEDFDA UDIA14-06260-04 EUDAMEDA14-05160-04 EUDAMEDA14-06360-04 EUDAMEDA14-05260-04 EUDAMED
- Description
- 5Fr x 60cm Single Lumen Synergy CT PICC Nursing Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00876604004818 EUDAMED00876604000681 EUDAMEDFDA UDI00876604004849 EUDAMED00876604004825 EUDAMED00876604004856 EUDAMED00876604004832 EUDAMED
- 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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Manufacturer's product page: SYNERGY CT PICC™ Line Max Barrier Kit
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101329 | Class III | Active |
| EUDAMED | European Union | CE/MDR | 087660400PP-PICC01001N8 | Class III | Active |
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Manufacturer
- Manufacturer
- Health Line International Corp
- EUDAMED SRN
- US-PR-000013766
Sources (8)
- EUDAMED 96099948-2066-4766-9488-9497c667753e 61 fields · synced Oct 5, 2026
- EUDAMED 11f4adae-2f17-4445-8d0a-6019ede4b390 61 fields · synced May 11, 2026
- EUDAMED 073c93f6-7ac8-4614-904d-8f769b3eea91 61 fields · synced May 16, 2026
- EUDAMED 5c1834a5-17b2-4e0a-9ddf-4d8d604bac44 61 fields · synced May 17, 2026
- EUDAMED 62757789-9d72-4923-88a9-25c4cd068570 61 fields · synced May 17, 2026
- EUDAMED a10330de-7efa-4f7c-b57e-6196701f941c 61 fields · synced May 18, 2026
- FDA UDI b61d9ca8-dc06-4d7b-b761-0b4e7407189f 34 fields · synced May 30, 2026
- FDA 510(k) K101329 1 fields · synced May 18, 2026