AccessGUDID - DEVICE: STAT PROFILE (00385480322041)

GUDID

Device Identifier (DI) Information

Brand Name: STAT PROFILE
Version or Model: PHOX PLUS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 32204
Company Name: NOVA BIOMEDICAL CORPORATION

Primary DI Number: 00385480322041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070617139 *Terms of Use

Device Description: Remanufactured Stat Profile pHOx Plus 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?
56668	Metabolic profile clinical chemistry analyser IVD, portable, semi-automated	A portable mains electricity (AC-powered) laboratory instrument, which may include internal rechargeable batteries, intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with reduced technician involvement and automation of some procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE
CGA	GLUCOSE OXIDASE, GLUCOSE
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
JPI	DEVICE, HEMATOCRIT MEASURING
GJS	TEST, TIME, PROTHROMBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002613	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
Special Storage Condition, Specify: 0 ft to 15000 ft
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Without Condensation
Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9da376a9-d9e2-42c2-9db2-9fe948eb8009
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10385480322048	1	00385480322041		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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