AccessGUDID - DEVICE: STAT PROFILE (00385480528566)

GUDID

Device Identifier (DI) Information

Brand Name: STAT PROFILE
Version or Model: PRIME CCS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 52856
Company Name: NOVA BIOMEDICAL CORPORATION

Primary DI Number: 00385480528566
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070617139 *Terms of Use

Device Description: Prime CCS Analyzer

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?
56671	Blood gas analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the calculation of other blood gas parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient] in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJS	CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE
KHP	ACID, LACTIC, ENZYMATIC METHOD
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
GKF	INSTRUMENT, HEMATOCRIT, AUTOMATED
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CGA	GLUCOSE OXIDASE, GLUCOSE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141907	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
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify: 0 ft to 12000 ft
Storage Environment Temperature: between 15 and 32 Degrees Celsius
Handling Environment Temperature: between 15 and 32 Degrees Celsius
Special Storage Condition, Specify: Without Condensation

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0291b51c-f9be-4767-9eb5-f158d8146102
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 06, 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
10385480528563	1	00385480528566		In Commercial Distribution	Box

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

Customer Contact

[?]

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

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