FDA.reportPublic FDA data

n.a.

Primary DI
04250105608359
Brand
n.a.
Company
VBM Medizintechnik GmbH
Model
56-03-100
Device description
Dispo Infusor; for single use; for rapid pressure infusion and irrigation purposes
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
true

Related Records

Contact Domains

Product Codes

CodeName
KZDInfusor, Pressure, For I.V. Bags

Product Code Classifications

CodeDeviceSpecialtyClass
KZDInfusor, Pressure, For I.V. BagsGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14250105608356PackageGS15In Commercial Distribution
04250105608359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1425010560835614250105608356
04250105608359042501056083594250105608359

GMDN Terms

TermDefinition
Intravenous pressure infusor, manualA manually-operated device designed to increase the rate of an intravenous (IV) solution given to a patient by applying pressure directly to the infusion bag. There are two main designs: 1) a flexible bag made of textile or clear plastic with a pocket to hold the infusion bag and an inflatable pressure chamber or cuff that, when inflated, applies the desired pressure -- included is a squeeze bulb for the operator to create the pressure, a line clamp, and a pressure gauge; and 2) a design similar to the first, but where the pressure is created typically using a mechanical screw or spring mechanism. This is a reusable device.

Device Sizes

TypeValueUnit
Total Volume1000Milliliter

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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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
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30889483601031Vital Signs™AIRLIFEKZD2025-07-31
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