AccessGUDID - DEVICE: Phoenix Diagnostics (10852676007121)

GUDID

Device Identifier (DI) Information

Brand Name: Phoenix Diagnostics
Version or Model: 1007AM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1007AM
Company Name: PHOENIX DIAGNOSTICS, INC.

Primary DI Number: 10852676007121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 606814960 *Terms of Use

Device Description: LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - L2

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:	Yes
Prescription Use (Rx):	No
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?
30218	Multiple blood gas analyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJS	Controls For Blood-Gases, (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K920285	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 2 and 8 Degrees Celsius
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Milliliter

Device Record Status

Public Device Record Key: bd4035e8-d153-493b-90ee-72e03cfd7827
Public Version Date: August 17, 2023
Public Version Number: 1
DI Record Publish Date: August 09, 2023

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: 00852676007124 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 5086558310
Email: sales@phoenixdiagnostics.com

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