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4l

FDA UDI

Class II (US FDA UDI)

by 4L Health Co., Ltd.

Identity

Trade Name
4L FDA UDI
Generic Name
Negative-pressure wound therapy system dressing set FDA UDI
Model / Reference
DK10AS FDA UDI

Identifiers

Primary DI / UDI-DI
06970076370113 FDA UDI
510(k) Number
K190119 FDA UDI
FDA Product Code
OMP FDA UDI
GMDN Term
Negative-pressure wound therapy system dressing 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

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
MRI Safety
MR Unsafe FDA UDI

Category: Negative-pressure wound therapy system dressing set

4l by 4L Health Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system dressing set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
4L Health Co., Ltd.

Sources (1)

  • FDA UDI e33875f9-ebd7-40f7-b238-9afba99059c4 33 fields · synced May 29, 2026