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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
Foetal scalp electrode, spiral FDA UDI
Device Name
Curaplex Oxygen Mask, Adult, Elongated, High Conc, Total NRB w/o Vent, Reservoir Bag, Tubing 50ea/cs FDA UDI
Model / Reference
533-MS-25060EA FDA UDI
Description
Curaplex Oxygen Mask, Adult, Elongated, High Conc, Total NRB w/o Vent, Reservoir Bag, Tubing 50ea/cs FDA UDI

Identifiers

Primary DI / UDI-DI
00815277027250 FDA UDI
FDA Product Code
BYG FDA UDI
GMDN Term
Foetal scalp electrode, spiral FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5580 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

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
Sterilization Method
Ethylene Oxide FDA UDI

Category: Foetal scalp electrode, spiral

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

Similar devices

Also classified as Foetal scalp electrode, spiral.

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 71b263f0-79a4-4f2f-abfb-792a94b90508 33 fields · synced May 30, 2026