AccessGUDID - DEVICE: O&P Collection Vials Formalin/C&S Kits (M445890211)

GUDID

Device Identifier (DI) Information

Brand Name: O&P Collection Vials Formalin/C&S Kits
Version or Model: 890-21
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 890-21
Company Name: MEDICAL CHEMICAL CORPORATION

Primary DI Number: M445890211
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 008496861 *Terms of Use

Device Description: Convenience kit containing C&S Vials and Buffered Formalin Vials.

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):	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?
57757	10% Neutral buffered formalin IVD	A 10% neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens.	Obsolete	false
58564	Carey-Blair transport medium IVD	A vessel containing transport medium intended to be used for the preservation and transport of gram negative and anaerobic microorganisms from a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IFP	Formalin, Neutral Buffered
JSM	Culture Media, Non-Propagating Transport

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d4bbdcda-23e2-4a59-b971-f518c7faa71e
Public Version Date: September 08, 2020
Public Version Number: 1
DI Record Publish Date: August 31, 2020