Edi Catheter ENFit 16Fr/125 cm, 5pcs

FDA UDIEUDAMED

Class II (US FDA UDI)

by Maquet Critical Care AB

Identity

Trade Name: Edi Catheter ENFit 16Fr/125 cm, 5pcs FDA UDI
Generic Name: Nasogastric feeding tube FDA UDI
Model / Reference: 6883904 FDA UDI

Identifiers

Primary DI / UDI-DI: 07325710004678 FDA UDI
510(k) Number: K153688 FDA UDI
FDA Product Code: PIF FDA UDI
CBK FDA UDI
GMDN Term: Nasogastric feeding tube FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5980 FDA UDI
868.5895 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Nasogastric feeding tube

Edi Catheter ENFit 16Fr/125 cm, 5pcs by Maquet Critical Care AB — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Nasogastric feeding tube.

MED-RX — Canadian Hospital Specialties Limited · Class II
ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector — ENVIZION MEDICAL LTD · Class II
NeoDevices, Inc. — NEODEVICES INC · Class II
CORFLO Enteral Feeding Tube — Corpak Medsystems · Class II
VYGON — Vygon Corp. · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class II
CORFLO Enteral Feeding Tube — Corpak Medsystems · Class II
Enteral — GBUK ENTERAL LIMITED · Class II

Cleared under the same submission

K153688 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Maquet Critical Care AB

Sources (2)

FDA UDI c28ef829-8d9d-4414-a1d3-8486ce5f1c44 33 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 19, 2026