AccessGUDID - DEVICE: pH/pCO2/pO2/Na/K/Ca Analyzer (00386100002596)

GUDID

Device Identifier (DI) Information

Brand Name: pH/pCO2/pO2/Na/K/Ca Analyzer
Version or Model: 7001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7001
Company Name: MEDICA CORPORATION

Primary DI Number: 00386100002596
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 112942404 *Terms of Use

Device Description: EasyStat pH/pCO2/pO2/Na/K/Ca 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?
56682	Ion-selective analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential against a reference electrode to determine the target ion concentration.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFP	Electrode, Ion Specific, Calcium
CEM	Electrode, Ion Specific, Potassium
JGS	Electrode, Ion Specific, Sodium
GKF	Instrument, Hematocrit, Automated
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021515	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 Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aefcaac0-f350-4ef1-a8e9-0dbd53ec7087
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: December 05, 2018

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

Customer Contact

[?]

Phone: 781-275-4892
Email: technicalsupport@medicacorp.com

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