AccessGUDID - DEVICE: Chemical Service Labs, LLC (00860011780540)

GUDID

Device Identifier (DI) Information

Brand Name: Chemical Service Labs, LLC
Version or Model: 30201
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Protean Resources, LLC.

Primary DI Number: 00860011780540
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078381126 *Terms of Use

Device Description: CSL Buffer: pH 6.8 (quart)

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):	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?
59119	Phosphate buffer/Sorenson buffer solution IVD	A phosphate buffer or Sorenson buffer solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCC	Ph Buffer

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: Store in tightly capped container at room temperature. Do not freeze. Keep away from flames.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1 Quart

Device Record Status

Public Device Record Key: b7d01ac3-84c6-42f1-8a6c-ee45b1480b87
Public Version Date: March 26, 2024
Public Version Number: 1
DI Record Publish Date: March 18, 2024