AccessGUDID - DEVICE: Ricca Chemical Company® (00192024025722)

GUDID

Device Identifier (DI) Information

Brand Name: Ricca Chemical Company®
Version or Model: 2330-16
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2330
Company Name: Ricca Chemical Company, LLC

Primary DI Number: 00192024025722
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020335667 *Terms of Use

Device Description: Copper Sulfate, 1.053 Specific Gravity at 25°C (77°F)

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?
33671	Copper sulfate solution IVD, reagent	A copper sulfate solution intended to be used alone or in combination with other IVDs for determining the concentration of haemoglobin in clinical specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSL	SOLUTION, COPPER SULFATE FOR SPECIFIC GRAVITY DETERMINATIONS

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a2e763d1-1375-444c-970c-1ac4c7778afb
Public Version Date: February 12, 2021
Public Version Number: 1
DI Record Publish Date: February 04, 2021