AccessGUDID - DEVICE: Mucolyse (10x100 mg) (20628429001008)

GUDID

Device Identifier (DI) Information

Brand Name: Mucolyse (10x100 mg)
Version or Model: PL.701
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL.701
Company Name: PRO-LAB, INCORPORATED

Primary DI Number: 20628429001008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 960418395 *Terms of Use

Device Description: Mucolyse presents an effective sputum digestant supplied in a simple, convenient, economical and safe format. Each vial, containing lyophilised predetermined quantities of Dithiothreitol and Phosphate Buffer, reconstitutes with 10 ml of sterile water, and then dilutes to 100 ml of active digestant solution.

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?
42624	Sputum liquefaction/decontamination reagent IVD	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the liquefaction, digestion, and/or decontamination of a sputum specimen suspected of containing microorganisms associated with respiratory disease (e.g., Streptococcus pneumoniae, Mycobacterium tuberculosis) in preparation for further processing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSK	Supplement, Culture Media

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: 274e35b1-c002-47d3-a2ab-79dbe5de8c03
Public Version Date: January 02, 2023
Public Version Number: 1
DI Record Publish Date: December 25, 2022