FDA.reportPublic FDA data

King Mask

Primary DI
00612649184890
Brand
King Mask
Company
Ambu A/S
Model
1065
Catalog number
1065
Device description
Disposable anesthesia face mask
Published
2023-01-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSJMASK, GAS, ANESTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612649100968PackageGS150In Commercial Distribution
00612649184890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612649100968006126491009686126491009680612649100968
00612649184890006126491848906126491848900612649184890

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, single-useA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-18 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

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
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05707480167609Ambu® Neuroline Monopolar74238-36/4074238-36/402026-09-05
05707480167630Ambu® Neuroline Monopolar74325-36/4074325-36/402026-09-05
05707480167661Ambu® Neuroline Monopolar74338-36/4074338-36/402026-09-05
05707480145287aScope™ Duodeno4820010004820010002020-08-10
05707480157402aScope™ Duodeno482001000/4482001000/42022-04-19
05707480136032Isiris™ MonitorMN0001MN00012018-07-30
05707480156306aScope™ 5 Broncho HD 5.0/2.2621001000US621001000US2022-08-19
05707480156337aScope™ 5 Broncho HD 5.6/2.8622001000US622001000US2022-08-19
05707480157259aScope™ 5 Broncho 4.2/2.2620001000US620001000US2023-08-25
05707480157280aScope™ 5 Broncho 2.7/1.2624001000US624001000US2023-08-25
05060038511034Ambu® WhiteSensor 4055440554405542026-08-07
05707480024650Ambu® Mini Perfit ACE™0002811060002811062022-12-08
05707480024674Ambu® Immobilization Kit, with0002811610002811612022-12-08
05707480026197BlueSensor NEOXECG ElectrodesNEOX-60-K/US/3NEOX-60-K/US/32016-09-21
05707480024513Ambu® Perfit Collar™0002642010002642012022-12-08
05707480024520Ambu® Perfit Collar™0002642020002642022022-12-08
05707480024537Ambu® Perfit Collar™0002642030002642032022-12-08
05707480024544Ambu® Perfit Collar™0002642040002642042022-12-08

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