AccessGUDID - DEVICE: Typenex Specimen Collection Swab (00810050852340)

GUDID

Device Identifier (DI) Information

Brand Name: Typenex Specimen Collection Swab
Version or Model: SW0104XNY
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SW0104XNY
Company Name: TYPENEX MEDICAL LLC

Primary DI Number: 00810050852340
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 600850213 *Terms of Use

Device Description: Specimen Collection Swab - Nasopharyngeal - New York

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?
57940	Oral/upper respiratory tract specimen collection swab	A piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for culture, analysis, and/or other investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXG	Applicator, Absorbent Tipped, Sterile

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: Yes
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
Length: 150 Millimeter

Device Record Status

Public Device Record Key: f6d5eccd-3666-49d1-9597-befddb879e54
Public Version Date: January 01, 2024
Public Version Number: 5
DI Record Publish Date: August 11, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00810050852357	100	00810050852340	2023-12-31	Not in Commercial Distribution	Case
10810050852354	1000	00810050852357	2023-12-31	Not in Commercial Distribution	Master Carton