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Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name
Curaplex FDA UDI
Generic Name
In-line CPAP set, non-nebulizing FDA UDI
Device Name
Capnoline Multi Pack (includes 10 #177268) Kit 20PK/CS FDA UDI
Model / Reference
8600-01297 FDA UDI
Description
Capnoline Multi Pack (includes 10 #177268) Kit 20PK/CS FDA UDI

Identifiers

Catalog Number
8600-01297 FDA UDI
Primary DI / UDI-DI
00817617029443 FDA UDI
FDA Product Code
CCK FDA UDI
GMDN Term
In-line CPAP set, non-nebulizing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1400 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: In-line CPAP set, non-nebulizing

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

Similar devices

Also classified as In-line CPAP set, non-nebulizing.

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 d07a3aa7-658f-4345-9bf1-71c7c94970f4 34 fields · synced May 29, 2026