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Avanos*

FDA UDI

Class I (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name
AVANOS* FDA UDI
Generic Name
Oral care kit, single-use FDA UDI
Device Name
BALLARD* Oral Care Swabs, Individually Wrapped FDA UDI
Model / Reference
12246 FDA UDI
Description
BALLARD* Oral Care Swabs, Individually Wrapped FDA UDI

Identifiers

Catalog Number
12246 FDA UDI
Primary DI / UDI-DI
00609038968742 FDA UDI
FDA Product Code
KXF FDA UDI
GMDN Term
Oral care kit, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6025 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Oral care kit, single-use

Avanos* by Avanos Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral care kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avanos Medical, Inc.

Sources (1)

  • FDA UDI 356d0477-7448-492d-a0bb-a67a0102b98c 35 fields · synced Jun 9, 2026