FDA.report

n.a.

Primary DI
14250105600022
Brand
n.a.
Company
VBM Medizintechnik GmbH
Model
35-40-205
Device description
Face Mask; Adult, medium
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
true

Related Records

Contact Domains

Product Codes

CodeName
BSJMask, Gas, Anesthetic

Product Code Classifications

CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14250105600022PackageGS110In Commercial Distribution
04250105600025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1425010560002214250105600022
04250105600025042501056000254250105600025

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep dry, keep away from sunlight and heat

Sterilization Methods

Method

Contacts

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

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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

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