AccessGUDID - DEVICE: WM Nasopharyngeal Swab (D040702031)

GUDID

Device Identifier (DI) Information

Brand Name: WM Nasopharyngeal Swab
Version or Model: 70203
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70203
Company Name: WHIP-MIX CORPORATION

Primary DI Number: D040702031
Issuing Agency: HIBCC
Commercial Distribution End Date: February 24, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 006385173 *Terms of Use

Device Description: Whip Mix Nasopharyngeal Swab is a 3D printed device designed to collect test samples from patient.

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?
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
No Device Sizes

Device Record Status

Public Device Record Key: 39d6c342-14e8-4577-8732-5b61fdba6ddb
Public Version Date: August 26, 2021
Public Version Number: 3
DI Record Publish Date: August 21, 2020