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Curaplex

FDA UDI

Class I (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name
Curaplex FDA UDI
Generic Name
Isolation gown, single-use FDA UDI
Device Name
Curaplex Personal Protection Kit w/ reusable mask, *EMP FOR AMAZON* FDA UDI
Model / Reference
670196-KITFBA FDA UDI
Description
Curaplex Personal Protection Kit w/ reusable mask, *EMP FOR AMAZON* FDA UDI

Identifiers

Catalog Number
670196-KITFBA FDA UDI
Primary DI / UDI-DI
00812277036947 FDA UDI
FDA Product Code
LYU FDA UDI
GMDN Term
Isolation gown, single-use 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

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Isolation gown, single-useIsolation gown, reusableInfectious waste spill kit

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 spill kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bound Tree Medical, Llc

Sources (1)

  • FDA UDI 2b808a3e-cd62-44da-939b-005fe071177c 34 fields · synced May 30, 2026