Avance

FDA UDI

Class II (US FDA UDI)

by Mölnlycke Health Care AB

Identity

Trade Name: Avance FDA UDI
Generic Name: Negative-pressure wound therapy tubing set FDA UDI
Model / Reference: 772009-00 FDA UDI

Identifiers

Catalog Number: 772009 FDA UDI
Primary DI / UDI-DI: 07323190166473 FDA UDI
510(k) Number: K161797 FDA UDI
FDA Product Code: OMP FDA UDI
GMDN Term: Negative-pressure wound therapy tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4780 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

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

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Negative-pressure wound therapy tubing set

Avance by Mölnlycke Health Care AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K161797 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: Mölnlycke Health Care AB

Sources (1)

FDA UDI 6f950ed5-0ad0-4f78-b969-db4ce715eeb6 34 fields · synced May 30, 2026