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OneScope Pro

FDA UDI

Class I (US FDA UDI)

by One-AI Healthcare, Inc

Identity

Trade Name
OneScope Pro FDA UDI
Generic Name
Video intubation laryngoscope blade FDA UDI
Device Name
Pro - Direct Adult Mac 3 Blade FDA UDI
Model / Reference
Pro - Direct Adult Mac 3 Blade FDA UDI
Description
Pro - Direct Adult Mac 3 Blade FDA UDI

Identifiers

Primary DI / UDI-DI
00860010859742 FDA UDI
FDA Product Code
CCW FDA UDI
LRC FDA UDI
GMDN Term
Video intubation laryngoscope blade FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5540 FDA UDI
874.4420 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

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Video intubation laryngoscope blade

OneScope Pro by One-AI Healthcare, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Video intubation laryngoscope blade.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
One-AI Healthcare, Inc

Sources (1)

  • FDA UDI 7f513ec9-1753-4a32-b85d-ad50fb11214d 34 fields · synced May 30, 2026