AccessGUDID - DEVICE: Abiogenix FAST Spiral Nasopharyngeal Swab (00860003936832)

GUDID

Device Identifier (DI) Information

Brand Name: Abiogenix FAST Spiral Nasopharyngeal Swab
Version or Model: NP-SWAB-080-1000-NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NP-SWAB-080-1000-NS
Company Name: ABIOGENIX INC

Primary DI Number: 00860003936832
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801937041 *Terms of Use

Device Description: FAST Spiral Nasopharyngeal Swab, 80 mm Break Point, Packaged and Non-Sterile, Case/1000

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
KXF	Applicator, Absorbent Tipped, Non-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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Depth: 80 Millimeter

Device Record Status

Public Device Record Key: f6eed64a-871a-42de-a0c6-feef6d165880
Public Version Date: July 22, 2021
Public Version Number: 3
DI Record Publish Date: May 29, 2020