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aScope™ 3 Regular 5.0/2.2Flexible Videoscope - Single Use

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name
aScope™ 3 Regular 5.0/2.2Flexible Videoscope - Single Use FDA UDI
Generic Name
Flexible video bronchoscope, single-use FDA UDI
Device Name
Ambu aScope 3 - Video Bronchioscope Single-Use, Flexible and Sterile. Insertion cord dia 5.0 mm, channel width of 2.2 mm. Bending angle of 150°/130° Min. ordering 5 pcs. = 1 box. FDA UDI
Model / Reference
403001000 FDA UDI
Description
Ambu aScope 3 - Video Bronchioscope Single-Use, Flexible and Sterile. Insertion cord dia 5.0 mm, channel width of 2.2 mm. Bending angle of 150°/130° Min. ordering 5 pcs. = 1 box. FDA UDI

Identifiers

Catalog Number
403001000 FDA UDI
Primary DI / UDI-DI
05707480121991 FDA UDI
FDA Product Code
EOQ FDA UDI
GMDN Term
Flexible video bronchoscope, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4680 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 600 Millimeter FDA UDI
Lumen/Inner Diameter — 2.2 Millimeter FDA UDI
Outer Diameter — 5 Millimeter FDA UDI

aScope™ 3 Regular 5.0/2.2Flexible Videoscope - Single Use by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ambu A/S

Sources (1)

  • FDA UDI 183f5204-3c39-481c-86a8-b0f36e4a2b53 38 fields · synced May 30, 2026