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Aura40

FDA UDI

Class I (US FDA UDI)

by Ambu A/S

Identity

Trade Name
Aura40 FDA UDI
Generic Name
Laryngeal mask airway, single-use FDA UDI
Device Name
Reusable Laryngeal Mask FDA UDI
Model / Reference
326250000U FDA UDI
Description
Reusable Laryngeal Mask FDA UDI

Identifiers

Catalog Number
326250000U FDA UDI
Primary DI / UDI-DI
05707480037674 FDA UDI
FDA Product Code
CAE FDA UDI
GMDN Term
Laryngeal mask airway, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5110 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Laryngeal mask airway, single-use

Aura40 by Ambu A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laryngeal mask airway, single-use.

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 f6789a65-06d4-42db-a0d6-a6474e8878a1 36 fields · synced Jun 8, 2026