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Synergy-XS CT PICC

EUDAMEDFDA UDI

Class III (EU MDR)

Ref A14-04260-IR

by Health Line International Corp

Identity

Trade Name
Synergy-XS CT PICC EUDAMED
Synergy XS FDA UDI
Generic Name
Peripherally-inserted central venous catheter FDA UDI
Device Name
PICC Procedure Pack EUDAMED
4Fr x 60cm Dual Lumen Synergy-XS CT PICC IR Kit FDA UDI
Model / Reference
A14-04260-IR EUDAMEDFDA UDI
Description
4Fr x 60cm Dual Lumen Synergy-XS CT PICC IR Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00876604000919 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 EUDAMED
Class 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-XS 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-XS CT PICC™ Line Kits

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Health Line International Corp
EUDAMED SRN
US-PR-000013766

Sources (2)

  • EUDAMED bde5cc89-b281-4e64-9e4c-047c5eed098f 61 fields · synced Oct 6, 2026
  • FDA UDI 2de75b2f-b46a-4171-8f84-e516000ec38f 34 fields · synced May 30, 2026