AuraFlex 327500000U

GUDID 05707480037902

Ambu Auraflex U Size 5

Ambu A/S

Laryngeal mask airway, single-use
Primary Device ID05707480037902
NIH Device Record Keya2eeb5ef-ad6e-43cc-8154-78a2baed2f5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAuraFlex
Version Model Number327500000U
Catalog Number327500000U
Company DUNS305682023
Company NameAmbu A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS105707480037889 [Package]
Contains: 05707480037896
Package: [10 Units]
In Commercial Distribution
GS105707480037896 [Primary]
GS105707480037902 [Package]
Contains: 05707480037889
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 [AuraFlex]

05707480037810Ambu Auraflex U Size 2.5
05707480037919Ambu Auraflex U Size 6
05707480037902Ambu Auraflex U Size 5
05707480037858Ambu Auraflex U Size 4
05707480037841Ambu Auraflex U Size 3
05707480037766Ambu Auraflex U Size 2

Trademark Results [AuraFlex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AURAFLEX
AURAFLEX
75599780 2316249 Dead/Cancelled
Alfa Biotech S.p.A.
1998-12-04
AURAFLEX
AURAFLEX
74130574 1732399 Dead/Cancelled
THERIAK S.A.
1991-01-15

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