FDA.report

STATCORP MEDICAL

Primary DI
10841522124396
Brand
STATCORP MEDICAL
Company
Statcorp Medical
Model
STATCORP
Catalog number
2904SGA-24
Device description
UNIFUSOR II,1000ML,PISTON,STOPCOCK,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

Related Records

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
10841522124396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084152212439610841522124396

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods

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

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10841522130472SoftcheckSoftCheck BP Cuffs715-3031-002025-03-13
10841522130489SoftcheckSoftCheck BP Cuffs715-3032-002025-03-13
10841522130496SoftcheckSoftCheck BP Cuffs715-3041-002025-03-13
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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
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10841522128073UnifusorUnifusor899S2019-08-20
30841522111703SoftcheckSoftcheckVST1826MQML2016-10-04
30841522111727SoftcheckSoftcheckVST1826MQML52016-10-04
30841522111833SoftcheckSoftcheckVST2635MQML2016-10-04
30841522111857SoftcheckSoftcheckVST2635MQML52016-10-04
30841522128572StatcorpStatcorpBRDT3854DM2019-08-20
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