AccessGUDID - DEVICE: Thermo Scientific Protocol™ Parasitology System (00845275005004)

GUDID

Device Identifier (DI) Information

Brand Name: Thermo Scientific Protocol™ Parasitology System
Version or Model: 23-005-37
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fisher Diagnostics

Primary DI Number: 00845275005004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 183998769 *Terms of Use

Device Description: No description.

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?
57908	Faecal specimen container IVD, polyvinyl alcohol (PVA) fixative	A covered plastic receptacle containing polyvinyl alcohol (PVA) fixative solution intended to be used for the collection, and preservation and/or transport, of a faecal specimen for analysis and/or other investigation. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LDZ	Fixative, Alcohol Containing

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
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: c2c2f73b-3e17-430f-946b-b2a2b6e99196
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016