REPROCESSING PRODUCTS CORPORATION

Address:1643 W Modern Ct,TUCSON,AZ,85705,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Strip, Dialysate Ph Indicator (MNV) (4) Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (MSY) (2) Detector, Leak, Blood (FJD) (1) Dialyzer Reprocessing System (LIF) (1) Dialyzer, Capillary, Hollow Fiber (FJI) (1) Tape And Bandage, Adhesive (KGX) (1)

Premarket Exempt

No Yes

Clear

EZ-Chek - 00858293006106 Catalog Number : K100-0111

Device Description : Ozone (in Water) Test Strips

Device Class :

Duns Number: 796083392

Premarket Exempt : No

Product Code : MSY

Prescription Use : Yes

Device Count : 1

Micro-X - 00858293006113 Catalog Number : K100-0100

Device Description : Micro-X Residual Test Strips

Device Class : 2

Duns Number: 796083392

Premarket Exempt : No

Product Code : MSY

Prescription Use : Yes

Device Count : 1

Micro-X - 00858293006120 Catalog Number : K100-0105

Device Description : Micro-X Peracetic Acid Test Strips - Potency

Device Class : 2

Duns Number: 796083392

Premarket Exempt : No

Product Code : LIF

Prescription Use : Yes

Device Count : 1

EZ-Chek - 00858293006137 Catalog Number : K100-0117

Device Description : 6.8 - 8.5 pH Test Strips acid/bicarbonate dialysate 100/btl

Device Class :

Duns Number: 796083392

Premarket Exempt : No

Product Code : MNV

Prescription Use : Yes

Device Count : 1

EZ-Chek - 00858293006144 Catalog Number : K100-0117CT

Device Description : 6.8 - 8.5 pH Test Strips citric acid/bicarbonate dialysate

Device Class : 2

Duns Number: 796083392

Premarket Exempt : No

Product Code : MNV

Prescription Use : Yes

Device Count : 1

EZ-Chek - 00858293006151 Catalog Number : K100-0104

Device Description : 0 -14 pH Test Strips

Device Class : 2

Duns Number: 796083392

Premarket Exempt : No

Product Code : MNV

Prescription Use : Yes

Device Count : 1

EZ-Chek - 00858293006168 Catalog Number : K100-0104.5

Device Description : 4.5 - 10 pH Test Strips

Device Class : 2

Duns Number: 796083392

Premarket Exempt : No

Product Code : MNV

Prescription Use : Yes

Device Count : 1

EZ-Chek - 00858293006175 Catalog Number : K100-0114

Device Description : Blood Leak Test Strips

Device Class :

Duns Number: 796083392

Premarket Exempt : No

Product Code : FJD

Prescription Use : Yes

Device Count : 1

CathGuard - 00858293006182 Catalog Number :

Device Description : Patient Catheter Protective Pocket

Device Class : 1

Duns Number: 796083392

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Dialysate Port Caps 1.5" - 00858293006212 Catalog Number :

Device Class : 2

Duns Number: 796083392

Premarket Exempt : No

Product Code : FJI

Prescription Use : No

Device Count : 1

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