FDA.reportPublic FDA data

STATCORP MEDICAL

Primary DI
10841522124389
Brand
STATCORP MEDICAL
Company
Statcorp Medical
Model
STATCORP
Catalog number
2904TGA-24
Device description
UNIFUSOR II,1000ML,PISTON,THUMBWHEEL,24/BX
Published
2018-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
10841522124389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152212438910841522124389

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
602075905
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
false
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
10841522130458SoftcheckSoftCheck BP Cuffs715-3021-002025-03-13
10841522130465SoftcheckSoftCheck BP Cuffs715-3022-002025-03-13
10841522130472SoftcheckSoftCheck BP Cuffs715-3031-002025-03-13
10841522130489SoftcheckSoftCheck BP Cuffs715-3032-002025-03-13
10841522130496SoftcheckSoftCheck BP Cuffs715-3041-002025-03-13
10841522130519SoftcheckSoftCheck BP Cuffs715-3012-052025-03-13
10841522130526SoftcheckSoftCheck BP Cuffs715-3022-052025-03-13
10841522130533SoftcheckSoftCheck BP Cuffs715-3032-052025-03-13
10841522130540SoftcheckSoftCheck BP Cuffs715-3042-052025-03-13
10841522130601SoftCheckSoftCheck BP Cuffs3009167-0562025-03-13
10841522128066UnifusorUnifusor899F2019-08-20
10841522128073UnifusorUnifusor899S2019-08-20
30841522111703SoftcheckSoftcheckVST1826MQML2016-10-04
30841522111727SoftcheckSoftcheckVST1826MQML52016-10-04
30841522111833SoftcheckSoftcheckVST2635MQML2016-10-04
30841522111857SoftcheckSoftcheckVST2635MQML52016-10-04
30841522128572StatcorpStatcorpBRDT3854DM2019-08-20
10841522128592UltraCheckUltraCheck BP CuffsBRUD3854MB2024-06-07
10841522130434TrulinkSoftCheck BP Cuffs715-3011-002024-06-07
10841522130441TrulinkSoftCheck BP Cuffs715-3012-002024-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30889483600966Vital Signs™AIRLIFEKZD2025-07-31
30889483600980Vital Signs™AIRLIFEKZD2025-07-31
30889483600997Vital Signs™AIRLIFEKZD2025-07-31
30889483601017Vital Signs™AIRLIFEKZD2025-07-31
30889483601031Vital Signs™AIRLIFEKZD2025-07-31
30889483642362Vital Signs™SUNMED, LLCKZD2025-07-31
30889483642386Vital Signs™SUNMED, LLCKZD2025-07-31
30889483642409Vital Signs™SUNMED, LLCKZD2025-07-31
10816317024274Medline Pressure Infuser Bag 1000mlRENU MEDICAL, INCKZD2024-12-02
10816317024281Medline Pressure Infuser Bag 500mlRENU MEDICAL, INCKZD2024-12-02
06945040106197CONTECContec Medical Systems Co., Ltd.KZD2024-11-11
00811220035495PremierProSVS LLCKZD2024-10-28
00811220035518PremierProSVS LLCKZD2024-10-28
20889483230777InfuseOneETHOX MEDICAL, LLCKZD2024-07-01
20889483230784InfuseOneETHOX MEDICAL, LLCKZD2024-07-01
04719871892282JBCFOREMOUNT ENTERPRISE CO., LTD.KZD2024-06-28
04719871892299JBCFOREMOUNT ENTERPRISE CO., LTD.KZD2024-06-28
09008247000600automatic pressure infusorBiegler GmbHKZD2024-06-07
06971919460602BieglerNingbo Albert Novosino Co.,Ltd.KZD2024-05-24
06971919460619BieglerNingbo Albert Novosino Co.,Ltd.KZD2024-05-24
06971919460626BieglerNingbo Albert Novosino Co.,Ltd.KZD2024-05-24
06971919460633BieglerNingbo Albert Novosino Co.,Ltd.KZD2024-05-24
06971919460657BieglerNingbo Albert Novosino Co.,Ltd.KZD2024-05-24
06971919460664BieglerNingbo Albert Novosino Co.,Ltd.KZD2024-05-24
10884450777715Merit Medical®Merit Medical Systems, Inc.KZD2024-04-09
10884450777722Merit Medical®Merit Medical Systems, Inc.KZD2024-04-09
10884450777739Merit Medical®Merit Medical Systems, Inc.KZD2024-03-07
20193489033103MedlineMEDLINE INDUSTRIES, INC.KZD2024-01-16
20193489033110MedlineMEDLINE INDUSTRIES, INC.KZD2024-01-16
20197344020505MedlineMEDLINE INDUSTRIES, INC.KZD2023-12-21