AccessGUDID - DEVICE: Molecular Transport Media (MTM) 3ml (07898996204655)

GUDID

Device Identifier (DI) Information

Brand Name: Molecular Transport Media (MTM) 3ml
Version or Model: MEI00211
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MEI00211
Company Name: A. L. B. LUZ

Primary DI Number: 07898996204655
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 905130480 *Terms of Use

Device Description: The Molecular Transport Media is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS COV-2 virus RNA. These devices can be used for the collection transport and storage of specimens at 15-35 °C. Specimens collected and stored in a Molecular Transport Media are suitable for use with legally marketed molecular diagnostic devices.

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:	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?
61164	Oral/upper respiratory tract specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QBD	Microbial Nucleic Acid Storage And Stabilization Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233324	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5cba46be-6d59-4432-b3b7-5699a2648541
Public Version Date: September 06, 2024
Public Version Number: 1
DI Record Publish Date: August 29, 2024