AccessGUDID - DEVICE: WaterCheck2 (G212CM20201)

GUDID

Device Identifier (DI) Information

Brand Name: WaterCheck2
Version or Model: CM20201
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ibt Scientific LLC

Primary DI Number: G212CM20201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016808871 *Terms of Use

Device Description: 1 bottle of 100 test strips to check residual chlorine in rinse water

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):	No
Over the Counter (OTC):	Yes
Kit:	No
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?
62444	Haemodialysis equipment residual chlorine test strip	A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change and visual comparison to a colour chart, the concentration of residual chlorine in water samples. It is typically used as a means to test whether chlorine has been adequately rinsed from haemodialysis equipment following disinfection. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FKP	System, Dialysate Delivery, Single Patient

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953854	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
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 30c47251-284c-40b0-9cc6-f900621e665e
Public Version Date: January 14, 2022
Public Version Number: 1
DI Record Publish Date: January 06, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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