FDA.reportPublic FDA data

n.a.

Primary DI
14250105628507
Brand
n.a.
Company
VBM Medizintechnik GmbH
Model
88-11-000
Device description
Small Infant Mask
Published
2020-08-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYWDevice, Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYWDevice, RebreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24250105628504PackageGS110Not in Commercial Distribution
14250105628507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2425010562850424250105628504
1425010562850714250105628507

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
+49745495960info@vbm-medical.de

Regulatory Flags#

DUNS number
324869601
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250105630770ScalpelCric30-08-447-12026-05-08
04250105623048n.a.33-80-650-12020-09-02
04250105624243n.a.33-81-650-12020-09-02
04250105605150Quicktrach I30-04-002-12026-04-23
04250105605167Quicktrach I30-04-004-12026-04-23
04250105612462Quicktrach I30-04-904-12026-04-23
04250105613292Quicktrach I30-04-902-12026-04-23
14250105606024Tourniquet 250015-12-5002022-06-27
04250105630459Ambu® SureSight TM Stylet; large3219000302025-07-02
04250105630442Ambu® SureSight TM Stylet; medium3219000202025-07-02
04250105630435Ambu® SureSight TM Stylet; small3219000102025-07-02
14250105630449Ambu® SureSight TM Stylet; medium3219000202025-07-02
14250105630456Ambu® SureSight TM Stylet; large32190002302025-07-02
04250105628111n.a.30-08-447-12020-11-09
14250105628118n.a.30-08-447-12020-11-09
14250105630524Paediatric Mask; Newborn88-11-0002025-04-25
14250105630531Paediatric Mask; Infant88-11-0012025-04-25
14250105630548Paediatric Mask; Child88-11-0022025-04-25
24250105630521Paediatric Mask; Newborn88-11-0002025-04-25
24250105630538Paediatric Mask; Infant88-11-0012025-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14250105630524Paediatric Mask; NewbornVBM Medizintechnik GmbHBYW2025-04-25
14250105630531Paediatric Mask; InfantVBM Medizintechnik GmbHBYW2025-04-25
14250105630548Paediatric Mask; ChildVBM Medizintechnik GmbHBYW2025-04-25
24250105630521Paediatric Mask; NewbornVBM Medizintechnik GmbHBYW2025-04-25
24250105630538Paediatric Mask; InfantVBM Medizintechnik GmbHBYW2025-04-25
24250105630545Paediatric Mask; ChildVBM Medizintechnik GmbHBYW2025-04-25
06975029700054MTEHFYAFBeijing Xingjian Yongzhen Technology Co. , Ltd.BYW2024-06-12
06975029700061MTEHFYAFBeijing Xingjian Yongzhen Technology Co. , Ltd.BYW2024-06-12
06975029700078MTEHFYAFBeijing Xingjian Yongzhen Technology Co. , Ltd.BYW2024-06-12
00840155400009MedSource Rebreather MaskMEDSOURCE INTERNATIONAL LLCBYW2021-05-27
00840155400047MedSource Rebreather MaskMEDSOURCE INTERNATIONAL LLCBYW2021-05-27
00840155400016MedSource Rebreather MaskMEDSOURCE INTERNATIONAL LLCBYW2021-05-27
00840155400054MedSource Rebreather MaskMEDSOURCE INTERNATIONAL LLCBYW2021-05-27
14250105628514n.a.VBM Medizintechnik GmbHBYW2020-08-25
14250105628521n.a.VBM Medizintechnik GmbHBYW2020-08-25
24250105628504n.a.VBM Medizintechnik GmbHBYW2020-08-25
24250105628511n.a.VBM Medizintechnik GmbHBYW2020-08-25
24250105628528n.a.VBM Medizintechnik GmbHBYW2020-08-25
00604351600515Monaghan Medical CorporationMonaghan Medical CorporationBYW2020-07-30
50604351600510Monaghan Medical CorporationMONAGHAN MEDICAL CORPORATIONBYW2020-07-30
00863034000329ANEclearANECARE, LLCBYW2018-02-27
10863034000326ANEclearANECARE, LLCBYW2018-02-27
00604351600508AE II BANMonaghan Medical CorporationBYW2017-07-25
50604351600503AE II BANMONAGHAN MEDICAL CORPORATIONBYW2017-07-25