AccessGUDID - DEVICE: AmeriWater 00BCM100 (00817927020291)

GUDID

Device Identifier (DI) Information

Brand Name: AmeriWater 00BCM100
Version or Model: 00BCM100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMERIWATER, LLC

Primary DI Number: 00817927020291
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 836758342 *Terms of Use

Device Description: 00BCM100 Manual Mix and Dispense Bicarb, 100 Gallon

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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?
36345	Haemodialysis bicarbonate solution preparation mixer	An electrically-powered unit intended to mix a bicarbonate concentrate(s), commonly in powder form, with water to produce a bicarbonate haemodialysis solution. It typically includes tanks with connection hoses, controls and display; some types may include solution delivery features.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIN	Tank, Holding, Dialysis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051031	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Liquid Chemical
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 49 Inch
Depth: 35 Inch
Height: 59 Inch
Weight: 195 Pound

Device Record Status

Public Device Record Key: 3a41d2c7-caf7-4a73-a254-fc0ae8b63a4d
Public Version Date: June 02, 2023
Public Version Number: 4
DI Record Publish Date: January 10, 2017

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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