AccessGUDID - DEVICE: EPOC READER (00809708016685)

GUDID

Device Identifier (DI) Information

Brand Name: EPOC READER
Version or Model: HR-1002-00-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HR-1002-00-00
Company Name: Epocal Inc

Primary DI Number: 00809708016685
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 201179681 *Terms of Use

Device Description: EPOC READER

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?
56667	Metabolic profile clinical chemistry analyser IVD	A portable, electrically-powered automated or semi-automated laboratory instrument 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)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEM	Electrode, Ion Specific, Potassium
CGA	Glucose Oxidase, Glucose
CGZ	Electrode, Ion-Specific, Chloride
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
JFP	Electrode, Ion Specific, Calcium
JGS	Electrode, Ion Specific, Sodium
KHP	Acid, Lactic, Enzymatic Method

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cdab5f72-22ba-42ae-adb5-3886073f664d
Public Version Date: September 16, 2022
Public Version Number: 6
DI Record Publish Date: July 05, 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
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: +1(877)229-3711
Email: CONTACT@SIEMENS-HEALTHINEERS.COM

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