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Extension Set, Mini Bore

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name
Extension Set, Mini Bore FDA UDI
Generic Name
Peripheral anaesthesia catheter set, non-medicated FDA UDI
Device Name
AVANOS* Extension Sets FDA UDI
Model / Reference
189A030 FDA UDI
Description
AVANOS* Extension Sets FDA UDI

Identifiers

Catalog Number
189A030 FDA UDI
Primary DI / UDI-DI
00193493985913 FDA UDI
510(k) Number
K070801 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Peripheral anaesthesia catheter set, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Peripheral anaesthesia catheter set, non-medicated

Extension Set, Mini Bore by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral anaesthesia catheter set, non-medicated.

Cleared under the same submission

K070801 also covers:

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 b4a28211-2541-47c4-9774-bef341a9b04a 36 fields · synced Jun 9, 2026