AccessGUDID - DEVICE: NOVA (00385480183420)

GUDID

Device Identifier (DI) Information

Brand Name: NOVA
Version or Model: 16
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18342
Company Name: NOVA BIOMEDICAL CORPORATION

Primary DI Number: 00385480183420
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070617139 *Terms of Use

Device Description: NOVA 16 EXTERNAL DILUENT

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?
58208	Buffered sample diluent IVD, manual	A buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JPK	MIXTURE, HEMATOLOGY QUALITY CONTROL
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE
JPI	DEVICE, HEMATOCRIT MEASURING
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
JFL	PH RATE MEASUREMENT, CARBON-DIOXIDE
CGA	GLUCOSE OXIDASE, GLUCOSE
JJC	ANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) CLINICAL USE
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
CDS	ELECTRODE, ION SPECIFIC, UREA NITROGEN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963005	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: 6509ef01-bcc2-41e0-8df3-c0ee007a59d8
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 24, 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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)545-6682
Email: info@novabio.com

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