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aScope™ 3 Large 5.8/2.8Flexible Videoscope - Single Use

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name
aScope™ 3 Large 5.8/2.8Flexible Videoscope - Single Use FDA UDI
Generic Name
Flexible video bronchoscope, single-use FDA UDI
Device Name
Ambu aScope 3 Large 5.8/2.8 Single-use flexible scope with insertion cord diameter of 5.8 mm and channel width up to 2.8 mm. Min. purchase is 5 pcs. = 1 box FDA UDI
Model / Reference
414001000 FDA UDI
Description
Ambu aScope 3 Large 5.8/2.8 Single-use flexible scope with insertion cord diameter of 5.8 mm and channel width up to 2.8 mm. Min. purchase is 5 pcs. = 1 box FDA UDI

Identifiers

Catalog Number
414001000 FDA UDI
Primary DI / UDI-DI
05707480133109 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
Lumen/Inner Diameter — 2.8 Millimeter FDA UDI
Outer Diameter — 5.8 Millimeter FDA UDI
Length — 600 Millimeter FDA UDI

aScope™ 3 Large 5.8/2.8Flexible 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 00bfb55a-b4b4-4264-b8f2-092c08d546f0 38 fields · synced May 30, 2026