AuraOnce 321600000U

GUDID 05707480025527

Ambu AuraOnce U Size 6

Ambu A/S

Laryngeal mask airway, single-use
Primary Device ID05707480025527
NIH Device Record Key109286f1-b2d7-4ed4-9c20-22ad1a0d1571
Commercial Distribution StatusIn Commercial Distribution
Brand NameAuraOnce
Version Model Number321600000U
Catalog Number321600000U
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
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Device Identifiers

Device Issuing AgencyDevice ID
GS105707480025442 [Package]
Package: [6 Units]
In Commercial Distribution
GS105707480025527 [Package]
Contains: 05707480025602
Package: [10 Units]
In Commercial Distribution
GS105707480025602 [Primary]

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 [AuraOnce]

05707480025565Ambu AuraOnce U Size 2.5
05707480025466Ambu AuraOnce U Size 1.5
05707480025527Ambu AuraOnce U Size 6
05707480025435Ambu AuraOnce U Size 5
05707480025503Ambu AuraOnce U Size 4
05707480025497Ambu AuraOnce U Size 3
05707480025473Ambu AuraOnce U Size 2
05707480025459Ambu AuraOnce U Size 1

Trademark Results [AuraOnce]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AURAONCE
AURAONCE
87671674 5553528 Live/Registered
AMBU A/S
2017-11-03

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