← Back to catalogue

Curaplex

FDA UDI

Class I (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name
Curaplex FDA UDI
Generic Name
Infectious waste absorbent FDA UDI
Device Name
Curaplex Personal Protection Kit Infection Control, incl Impervious Gown FDA UDI
Model / Reference
295814 FDA UDI
Description
Curaplex Personal Protection Kit Infection Control, incl Impervious Gown FDA UDI

Identifiers

Catalog Number
295814 FDA UDI
Primary DI / UDI-DI
00815277020770 FDA UDI
FDA Product Code
LYU FDA UDI
GMDN Term
Infectious waste absorbent FDA UDI

Classification

Device Class
Class I 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

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Isolation gown, single-useSurgical/medical respirator, non-antimicrobial, single-useShoe coverNitrile examination/treatment glove, non-powdered, antimicrobial

Curaplex by Bound Tree Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infectious waste absorbent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bound Tree Medical, Llc

Sources (1)

  • FDA UDI b0c9ec1b-64a3-4906-9718-34e9b1391232 34 fields · synced May 31, 2026