FDA.reportPublic FDA data

n.a.

Primary DI
24250105628511
Brand
n.a.
Company
VBM Medizintechnik GmbH
Model
88-11-001
Device description
Large Infant Mask
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
BYWDevice, Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYWDevice, RebreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24250105628511PackageGS110In Commercial Distribution
14250105628514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2425010562851124250105628511
1425010562851414250105628514

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

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
true
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
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
14250105628507n.a.VBM Medizintechnik GmbHBYW2020-08-25
14250105628514n.a.VBM Medizintechnik GmbHBYW2020-08-25
14250105628521n.a.VBM Medizintechnik GmbHBYW2020-08-25
24250105628504n.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