Baxter Tip Cap ENFit® Syringe Compatible

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name: Baxter Tip Cap ENFit® Syringe Compatible FDA UDI
Generic Name: Medicine bottle cap FDA UDI
Device Name: H93853305 ENFit Bax Tip Cap NonSterile White FDA UDI
Model / Reference: H93853305 FDA UDI
Description: H93853305 ENFit Bax Tip Cap NonSterile White FDA UDI

Identifiers

Catalog Number: H93853305 FDA UDI
Primary DI / UDI-DI: 00350770003115 FDA UDI
510(k) Number: K152857 FDA UDI
FDA Product Code: PNR FDA UDI
GMDN Term: Medicine bottle cap FDA UDI

Classification

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

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Medicine bottle cap

Baxter Tip Cap ENFit® Syringe Compatible by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K152857 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Avanos Medical, Inc.

Sources (1)

FDA UDI 093c741f-2eba-4b4f-86a7-a39f5cb254b9 36 fields · synced Jun 9, 2026