Aura-i 329400000U

GUDID 05707480100286

Ambu Aura-i U Size 4, Disposable Laryngeal Mask

Ambu A/S

Laryngeal mask airway, single-use
Primary Device ID05707480100286
NIH Device Record Key73f53559-9189-4b50-aadd-880a9a8c8d84
Commercial Distribution StatusIn Commercial Distribution
Brand NameAura-i
Version Model Number329400000U
Catalog Number329400000U
Company DUNS305682023
Company NameAmbu A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com
Phone+1(410)768-6464
EmailPurchase_orders@ambuUSA.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480044245 [Primary]
GS105707480100286 [Package]
Contains: 05707480044245
Package: [10 Units]
In Commercial Distribution
GS105707480114467 [Package]
Package: [8 Units]
In Commercial Distribution

FDA Product Code

CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-01-30
Device Publish Date2022-12-08

On-Brand Devices [Aura-i]

05707480100200Ambu Aura-i U Size 2.5, Disposable Laryngeal Mask
05707480100125Ambu Aura-i U Size 1.5, Disposable Laryngeal Mask
05707480100378Ambu Aura-i U Size 6, Disposable Laryngeal Mask
05707480100323Ambu Aura-i U Size 5, Disposable Laryngeal Mask
05707480100286Ambu Aura-i U Size 4, Disposable Laryngeal Mask
05707480100248Ambu Aura-i U Size 3, Disposable Laryngeal Mask
05707480100163Ambu Aura-i U Size 2, Disposable Laryngeal Mask
05707480100088Ambu Aura-i U Size 1, Disposable Laryngeal Mask

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.