AccessGUDID - DEVICE: Disposable PFT Nose Clip with Foam Pads (00817081021691)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable PFT Nose Clip with Foam Pads
Version or Model: Disposable PFT Nose Clip with Foam Pads - 166500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 166500
Company Name: A-M SYSTEMS, LLC

Primary DI Number: 00817081021691
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020275145 *Terms of Use

Device Description: Disposable Pulmonary Function Testing Nose Clip with Foam Pads

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?
10907	Nose clip, single-use	A device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function (e.g., spirometry), and/or to stop nosebleeds (epistaxis). It is typically constructed of plastic with rubber or foam tips. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXJ	Clip, Nose

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: 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: 22492db2-a0da-4434-bf2c-fb7430945ec3
Public Version Date: November 04, 2019
Public Version Number: 1
DI Record Publish Date: October 25, 2019