AccessGUDID - DEVICE: DTPM (06973471968763)

GUDID

Device Identifier (DI) Information

Brand Name: DTPM
Version or Model: ITMNO
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PV993240
Company Name: Shenzhen Dakewe Bio-engineering Co., Ltd

Primary DI Number: 06973471968763
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 543029175 *Terms of Use

Device Description: 3 mL of Inactivated Transport Medium in screw-cap tube, with nasopharyngeal swabs and oropharyngeal swabs.

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?
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 [?]
K220059	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: 411b9baf-11f1-413b-91d1-cbd71f33533d
Public Version Date: May 28, 2024
Public Version Number: 1
DI Record Publish Date: May 20, 2024