FDA.reportPublic FDA data

n.a.

Primary DI
14250105603955
Brand
n.a.
Company
VBM Medizintechnik GmbH
Model
30-55-500
Device description
Manual Suction Pump
Published
2020-08-26
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
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
14250105603955PackageGS11In Commercial Distribution
04250105603958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425010560395514250105603955
04250105603958042501056039584250105603958

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

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
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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