DEVICE: Nova Max (00385480434362)

Device Identifier (DI) Information

Nova Max
Plus
In Commercial Distribution
43436
NOVA BIOMEDICAL CORPORATION
00385480434362
GS1

1
070617139 *Terms of Use
Nova Max Plus Blood Glucose Monitoring System
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Home-use/point-of-care glucose analyser IVD, battery-powered An exclusively battery-powered instrument intended to be used by a layperson in the home or similar environment, or by health professionals at the point-of-care, for the quantitative in vitro measurement of glucose levels in whole blood. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system.
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FDA Product Code

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Product Code Product Code Name
JIN NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
JJX Single (specified) analyte controls (assayed and unassayed)
CGA GLUCOSE OXIDASE, GLUCOSE
NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
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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
Special Storage Condition, Specify: 0 ft to 10000 ft
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

422cd2a3-959b-450d-bdc6-061d6fca161e
March 29, 2018
2
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10385480434369 1 00385480434362 In Commercial Distribution Carton
20385480434366 4 10385480434369 In Commercial Distribution Carton
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Secondary DI

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

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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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(180)054-5668
info@novabio.com
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