FDA.reportPublic FDA data

automatic pressure infusor

Primary DI
09008247000600
Brand
automatic pressure infusor
Company
Biegler GmbH
Model
autopress
Device description
The automatic pressure infusor autopress is used when liquids are to be supplied under constant pressure.
Published
2024-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KZDInfusor, Pressure, For I.V. Bags

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZDInfusor, Pressure, For I.V. BagsGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008247000600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008247000600090082470006009008247000600

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous pressure infusor, automatedA pneumatically-powered device designed to increase the rate of an intravenous (IV) infusion given to a patient by applying pressure directly to the infusion bag. The device is designed with a pressure chamber into which the infusion bag is secured, and is connected to a supply of pressurized air which, when activated, creates pressure in the rear of the chamber. It typically includes a pressure gauge to indicate the applied pressure and overpressure safety features.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300451747
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09008247000235Extension Set250002024-06-04
09008247000242Extension Set350002024-06-04
19008247000232Extension Set250002024-06-04
19008247000249Extension Set350002024-06-04
09008247000259Extension Set460002020-06-19
09008247000501Blood and Infusion WarmerBW 6852020-06-19
19008247000843Extension Set460002020-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536933705BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933712BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933729BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933736BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933743BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933750BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933767BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933774BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00810132043789HCSConcordance Healthcare Solutions LLCKZD2026-05-13
00810132043796HCSConcordance Healthcare Solutions LLCKZD2026-05-13
00810132043680HCSConcordance Healthcare Solutions LLCKZD2025-10-23
00810132043697HCSConcordance Healthcare Solutions LLCKZD2025-10-23
00810132043703HCSConcordance Healthcare Solutions LLCKZD2025-10-23
10889483600962Vital Signs™AIRLIFEKZD2025-07-31
10889483600986Vital Signs™AIRLIFEKZD2025-07-31
10889483600993Vital Signs™AIRLIFEKZD2025-07-31
10889483601013Vital Signs™AIRLIFEKZD2025-07-31
10889483601037Vital Signs™AIRLIFEKZD2025-07-31
10889483642368Vital Signs™SUNMED, LLCKZD2025-07-31
10889483642382Vital Signs™SUNMED, LLCKZD2025-07-31
10889483642405Vital Signs™SUNMED, LLCKZD2025-07-31
00816317024277Medline Pressure Infuser Bag 1000mlRENU MEDICAL, INCKZD2024-12-02
00811220035488PremierProPRESTIGE AMERITECH, LTD.KZD2024-10-28
00811220035501PremierProPRESTIGE AMERITECH, LTD.KZD2024-10-28
10889483230770InfuseOneETHOX MEDICAL, LLCKZD2024-07-01
10889483230787InfuseOneETHOX MEDICAL, LLCKZD2024-07-01
10193489033106MedlineMEDLINE INDUSTRIES, INC.KZD2024-01-16
10193489033113MedlineMEDLINE INDUSTRIES, INC.KZD2024-01-16
10197344020508MedlineMEDLINE INDUSTRIES, INC.KZD2023-12-21
00816317022372Vital SignsRENU MEDICAL, INCKZD2023-06-27