AccessGUDID - DEVICE: Research and Diagnostic Systems (00815762021312)

GUDID

Device Identifier (DI) Information

Brand Name: Research and Diagnostic Systems
Version or Model: RCL002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RCL002
Company Name: RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

Primary DI Number: 00815762021312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 087248183 *Terms of Use

Device Description: "RET-LINE B 7 x 2.5mL (one of each level 1-6 + 1 base)"

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:	Yes
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?
30537	Reticulocyte count IVD, control	A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JPK	Mixture, Hematology Quality Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013898	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
Handling Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 17.5 Milliliter

Device Record Status

Public Device Record Key: 7cfa7abe-4fcc-400c-a790-6547c3337fc4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 29, 2016