Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Capillary blood collection set, home-use FDA UDI
Device Name: *Custom* ATF Medic Load Out Kit 2016 FDA UDI
Model / Reference: 8600-ATFMLOK FDA UDI
Description: *Custom* ATF Medic Load Out Kit 2016 FDA UDI

Identifiers

Primary DI / UDI-DI: 00815277028059 FDA UDI
FDA Product Code: BTM FDA UDI
OQU FDA UDI
OGK FDA UDI
KGZ FDA UDI
PEZ FDA UDI
CBP FDA UDI
FMF FDA UDI
GMDN Term: Capillary blood collection set, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5915 FDA UDI
868.5730 FDA UDI
868.1400 FDA UDI
878.4200 FDA UDI
880.5200 FDA UDI
868.5870 FDA UDI
880.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Capillary blood collection set, home-use

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

Similar devices

Also classified as Capillary blood collection set, home-use.

Everlywell Blood Collection Kit — Everly Health, Inc. · Class II
Express HIV-1 Test System — HOME ACCESS HEALTH CORP. · Class III
CHECK UP AMERICAL CHOLESTEROL PANEL — HOME ACCESS HEALTH CORP.
HIV-1 Standard Test System — HOME ACCESS HEALTH CORP. · Class III
Everlywell Blood Collection Kit — Everly Health, Inc. · Class II
Everlywell Blood Collection Kit — Everly Health, Inc. · Class II
Everlywell Blood and Saliva Collection Kit — Everly Health, Inc. · Class II
Everlywell Blood Collection Kit — Everly Health, Inc. · Class II

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

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

Manufacturer

Manufacturer: Bound Tree Medical, Llc

Sources (1)

FDA UDI 995a2797-3a87-4542-8b9c-b952d9d8b248 33 fields · synced Jun 8, 2026