FDA.reportPublic FDA data

n.a.

Primary DI
14250105628750
Brand
n.a.
Company
VBM Medizintechnik GmbH
Model
30-55-000
Catalog number
n.a.
Device description
Manual Suction Pump Set
Published
2021-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250105628753Direct MarkingGS10
14250105628750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250105628753042501056287534250105628753
1425010562875014250105628750

GMDN Terms#

Term, Definition table
TermDefinition
Emergency airway clearance suction system, manualA portable assembly of devices, which includes a non-surgical invasive component, intended to manually aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes a manually-powered (hand or foot-operated) suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight470Gram

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
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

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