HACH COMPANY

Address:100 DAYTON AVE.,AMES,IA,50010,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

Chlorine Meter (PSX) (8) Subsystem, Water Purification (FIP) (8) Dialyzer Reprocessing System (LIF) (1)

Premarket Exempt

Clear

HACH - 00851575007198 Catalog Number : 9638600

Device Description : TOP LEVEL ASSY, CM130

Device Class : 2

Duns Number: 091381780

Premarket Exempt : No

Product Code : FIP, PSX

Prescription Use : Yes

Device Count : 1

HACH - 00851575007242 Catalog Number : 9717300

Device Description : MONTHLY MAINTENANCE KIT, CM130

Device Class : 2

Duns Number: 091381780

Premarket Exempt : No

Product Code : PSX, FIP

Prescription Use : Yes

Device Count : 1

HACH - 00851575007273 Catalog Number : 9746600

Device Description : PERFORMANCE CHECK KIT, CM130

Device Class : 2

Duns Number: 091381780

Premarket Exempt : No

Product Code : FIP, PSX

Prescription Use : Yes

Device Count : 1

HACH - 00851575007297 Catalog Number : 9638900

Device Description : ASSY, TUBING MAINTENANCE KIT, CM130

Device Class : 2

Duns Number: 091381780

Premarket Exempt : No

Product Code : PSX, FIP

Prescription Use : Yes

Device Count : 1

HACH - 00851575007310 Catalog Number : 9747300

Device Description : SAMPLE CONDITIONING/SPEAKER MODULE REPLACEMENT KIT

Device Class : 2

Duns Number: 091381780

Premarket Exempt : No

Product Code : FIP, PSX

Prescription Use : Yes

Device Count : 1

HACH - 00851575007334 Catalog Number : 9747400

Device Description : REAGENT DELIVERY MODULE REPLACEMENT KIT

Device Class : 2

Duns Number: 091381780

Premarket Exempt : No

Product Code : PSX, FIP

Prescription Use : Yes

Device Count : 1

HACH - 00851575007358 Catalog Number : 9747500

Device Description : STIR MOTOR REPLACEMENT MODULE KIT

Device Class : 2

Duns Number: 091381780

Premarket Exempt : No

Product Code : FIP, PSX

Prescription Use : Yes

Device Count : 1

HACH - 00851575007365 Catalog Number : 9756600

Device Description : MONTHLY MAINTENANCE KIT 6-PACK, CM130 (Model Number 9756600; Primary DI Number 0 MONTHLY MAINTENANCE KIT 6-PACK, CM130 (Model Number 9756600; Primary DI Number 00851575007365) that contains 6 individual MONTHLY MAINTENANCE KITs (Model Number 9717300; Primary DI Number 00851575007242)

Device Class : 2

Duns Number: 091381780

Premarket Exempt : No

Product Code : FIP, PSX

Prescription Use : Yes

Device Count : 1

Stericide Peroxide Reagent Strips - 00851575007389 Catalog Number : 811905B

Device Description : Reagent test strips used to measure the concentration of residual peroxide in ri Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid.

Device Class : 2

Duns Number: 091381780

Premarket Exempt : No

Product Code : LIF

Prescription Use : No

Device Count : 1

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