AccessGUDID - DEVICE: HACH (00851575007365)

GUDID

Device Identifier (DI) Information

Brand Name: HACH
Version or Model: 9756600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9756600
Company Name: HACH COMPANY

Primary DI Number: 00851575007365
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 091381780 *Terms of Use

Device Description: 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 Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62446	Haemodialysis system chlorine monitor	A mains electricity (AC-powered) component of a haemodialysis system intended to continuously measure total chlorine (total chloramines plus free chlorine) levels in water used to prepare dialysate. It performs sample collection and consists of an automated electronic assembly with a photometric colorimeter, chemical reagents which produce a colour change upon reaction with chlorine/chloramine, a stir motor, and a digital display screen to indicate chlorine concentration.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	Subsystem, Water Purification
PSX	Chlorine Meter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162471	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 69ea857d-a98f-4222-b045-068b0cb1276b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 12, 2017