FDA.reportPublic FDA data

Aura-i

Primary DI
05707480044283
Brand
Aura-i
Company
Ambu A/S
Model
329600000U
Catalog number
329600000U
Device description
Ambu Aura-i U Size 6, Disposable Laryngeal Mask
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707480100361PackageGS110In Commercial Distribution
05707480100378PackageGS16In Commercial Distribution
05707480044283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480100361057074801003615707480100361
05707480100378057074801003785707480100378
05707480044283057074800442835707480044283

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mask airway, single-useA curved tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway. It may include a 15 mm connector that attaches to a breathing circuit or manual resuscitator, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring. It is available in various sizes/designs and is typically made of silicone/plastic materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
305682023
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05707480024438Head Wedge™0002640340002640342022-12-08
05707480024476Head Wedge™0002640360002640362022-12-08
05707480024490Military Head Wedge™0002640640002640642022-12-08
05707480135363SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5206111015206111012017-10-13
05707480135585SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5236310115236310112018-07-09
05707480135615SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator5306390115306390112017-10-13
05707480136018SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator5442160475442160472018-05-28
05707480145294SPUR® II Adult Resuscitator5246140005246140002020-06-24
05707480145317SPUR® II Pediatric Resuscitator5316160005316160002020-06-24
05707480145348SPUR® II Adult Resuscitator5206110745206110742020-06-24
05707480145393SPUR® II Adult Resuscitator520211000BE520211000BE2021-04-13
05707480145416SPUR® II Adult Resuscitator520211000E520211000E2021-04-13
05707480145430SPUR® II Adult Resuscitator520211001E520211001E2021-04-13
05707480145454SPUR® II Adult Resuscitator520211010E520211010E2021-04-13
05707480145478SPUR® II Adult Resuscitator520214000E520214000E2021-04-13
05707480145492SPUR® II Adult Resuscitator520611000E520611000E2021-04-13
05707480145515SPUR® II Adult Resuscitator521611000E521611000E2021-04-13
05707480145539SPUR® II Adult Resuscitator523211000E523211000E2021-04-13
05707480145553SPUR® II Adult Resuscitator523211001E523211001E2021-04-13
05707480145577SPUR® II Adult Resuscitator523611030E523611030E2021-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05030267169870I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169894I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.0, SMALL PAEDIATRIC, 10-25KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169917I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169931I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169955I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169979I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.5, INFANT, 5-12KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169993I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.5, LARGE PAEDIATRIC, 25-35KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267170012I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267170036I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267170050I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)Intersurgical IncorporatedCAE2026-06-02
04816415501409SINGLE-USE OROPHARYNGEAL AIRWAY 40 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501416SINGLE-USE OROPHARYNGEAL AIRWAY 90 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501423SINGLE-USE OROPHARYNGEAL AIRWAY 110 mmASSOMEDIKA, OOOCAE2026-05-27
10197344165605MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165612MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165629MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165636MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165643MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165650MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165667MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165674MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
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10801902154078LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
10801902154085LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
10801902153972LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902153989LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902153996LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154009LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154016LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30