FDA.reportPublic FDA data

n.a.

Primary DI
04250105620184
Brand
n.a.
Company
VBM Medizintechnik GmbH
Model
35-65-222
Device description
Bi-Mask with silicone lip
Published
2020-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04250105620184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250105620184042501056201844250105620184

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, reusableA 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 reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep dry, keep away from sunlight and heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49745495960info@vbm-medical.de

Regulatory Flags#

DUNS number
324869601
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250105630435Ambu® SureSight TM Stylet; small3219000102025-07-02
14250105630449Ambu® SureSight TM Stylet; medium3219000202025-07-02
14250105630456Ambu® SureSight TM Stylet; large32190002302025-07-02
14250105628118n.a.30-08-447-12020-11-09
24250105630521Paediatric Mask; Newborn88-11-0002025-04-25
24250105630538Paediatric Mask; Infant88-11-0012025-04-25
24250105630545Paediatric Mask; Child88-11-0022025-04-25
04250105630299Sampling Line61-99-1502025-04-15
14250105630302Sampling Line61-99-2002025-04-15
04250105630312Sampling Line61-99-3002025-04-15
04250105630329Right Angled Connector60-60-0022025-04-15
14250105630333Right Angled Connector60-60-0042025-04-15
14250105630340Right Angled Connector60-60-0102025-04-15
14250105630357Right Angled Connector60-60-2052025-04-15
04250105630367Right Angled Connector60-60-3052025-04-15
14250105630371Right Angled Connector60-60-0052025-04-15
04250105609660n/a20-10-3332019-10-08
04250105629798Bronchoscope Airway30-40-420-12024-11-04
04250105629804Bronchoscope Airway30-40-440-12024-11-04
04250105629415Clear Infusor57-02-3002023-01-31

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
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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