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5r Med

FDA UDI

Class II (US FDA UDI)

by 5r Med Instruments (Chengdu) Co., Ltd.

Identity

Trade Name
5R MED FDA UDI
Generic Name
Surgical/medical face mask, single-use FDA UDI
Device Name
Medical Face Mask FDA UDI
Model / Reference
5R-DM FDA UDI
Description
Medical Face Mask FDA UDI

Identifiers

Primary DI / UDI-DI
06973675392036 FDA UDI
FDA Product Code
FXX FDA UDI
GMDN Term
Surgical/medical face mask, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4040 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

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Category: Surgical/medical face mask, single-use

5r Med by 5r Med Instruments (Chengdu) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical face mask, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
5r Med Instruments (Chengdu) Co., Ltd.

Sources (1)

  • FDA UDI 0ccee4d4-94b4-4ead-9226-9be8d888550f 34 fields · synced May 30, 2026