FDA.reportPublic FDA data

King Mask

Primary DI
00612649100890
Brand
King Mask
Company
Ambu A/S
Model
1055
Catalog number
1055
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
OTC
false
Sterile
false
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
00612649100890PackageGS150In Commercial Distribution
00612649184869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612649100890006126491008906126491008900612649100890
00612649184869006126491848696126491848690612649184869

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
305682023
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05707480145591SPUR® II Adult Resuscitator523611031E523611031E2021-04-13
05707480027354SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5232110005232110002016-12-19
05707480027361SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5232110015232110012016-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501287BREATHING MASK Single Use Size 0ASSOMEDIKA, OOOBSJ2026-05-26
04816415501294BREATHING MASK Single Use Size 3ASSOMEDIKA, OOOBSJ2026-05-26
04816415501300BREATHING MASK Single Use Size 6ASSOMEDIKA, OOOBSJ2026-05-26
04816415501317BREATHING MASK Reusable Size 0ASSOMEDIKA, OOOBSJ2026-05-26
04816415501324BREATHING MASK Reusable Size 3ASSOMEDIKA, OOOBSJ2026-05-26
04816415501331BREATHING MASK Reusable Size 5ASSOMEDIKA, OOOBSJ2026-05-26
50192253071410CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071427CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071434CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071441CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071458CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
50192253071465CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
44710810080836N/AGALEMED CORPORATIONBSJ2026-03-05
44710810081789N/AGALEMED CORPORATIONBSJ2026-03-05
44710810081819N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082250N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082267N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082403N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082410N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082427N/AGALEMED CORPORATIONBSJ2026-03-05
44710810082489N/AGALEMED CORPORATIONBSJ2026-03-05
44710810086449N/AGALEMED CORPORATIONBSJ2026-03-05
44710810088702N/AGALEMED CORPORATIONBSJ2026-03-05
44710810115781N/AGALEMED CORPORATIONBSJ2026-03-05
44710810117631N/AGALEMED CORPORATIONBSJ2026-03-05
44710810117624N/AGALEMED CORPORATIONBSJ2026-03-04
05030267124084ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15MIntersurgical IncorporatedBSJ2025-09-25
05030267124091ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15MIntersurgical IncorporatedBSJ2025-09-25
05030267124107ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22FIntersurgical IncorporatedBSJ2025-09-25
05030267123582ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22FIntersurgical IncorporatedBSJ2025-09-25