DEVICE: MCB Series (00817492021013)

Device Identifier (DI) Information

MCB Series
MCB 202-50 BICARB SNGL SYS
In Commercial Distribution

MAR COR PURIFICATION, INC.
00817492021013
GS1

1
019056181 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
FIN Tank, Holding, Dialysis
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: more than 32 Degrees Fahrenheit
Handling Environment Temperature: more than 32 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Weight: 90 Pound
Height: 43 Inch
Depth: 36 Inch
Width: 42 Inch
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Device Record Status

d1247bee-12e6-43f6-a0f5-85447585898c
June 02, 2023
4
September 23, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
8006333080
info@mcpur.com
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