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Guide wire for Edi Catheter 6 Fr

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref 6671270

by Maquet Critical Care AB

Identity

Trade Name
Guide wire for Edi Catheter 6 Fr EUDAMED
Guide Wire for Edi catheter 6Fr/ 49 and 50 cm FDA UDI
Generic Name
Nasogastric feeding tube FDA UDI
Device Name
Guide wire for Edi Catheter EUDAMED
Model / Reference
6671270 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
07325710006542 EUDAMEDFDA UDI
Basic UDI-DI
7325710006528Y EUDAMED
FDA Product Code
KNT FDA UDI
EMDN Code
G0280 GASTROINTESTINAL TUBES - ACCESSORIES EUDAMED
GMDN Term
Nasogastric feeding tube FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Guide wire for Edi Catheter 6 Fr by Maquet Critical Care AB — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Maquet Critical Care AB
EUDAMED SRN
SE-MF-000001264

Sources (3)

  • EUDAMED 762f8599-0897-4da5-90d3-d16010df98af 61 fields · synced Oct 7, 2026
  • FDA UDI 992cc53f-d44f-44c3-8147-6616607aaa4a 32 fields · synced May 30, 2026
  • FDA 510(k) K153461 1 fields · synced May 18, 2026