AccessGUDID - DEVICE: Pasture F550G Respirator (B624F550G200)

GUDID

Device Identifier (DI) Information

Brand Name: Pasture F550G Respirator
Version or Model: F550G
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PASTURE PHARMA PTE LTD

Primary DI Number: B624F550G200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 628369480 *Terms of Use

Device Description: This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies.

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):	Yes
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?
57793	Public respirator, single-use	A form-shaped filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large and small particles when considered necessary (e.g., viral epidemic). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZJ	Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083176	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
Handling Environment Humidity: less than 50 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d25ed0dc-1bfb-4499-b1c8-78e6865135b9
Public Version Date: September 13, 2023
Public Version Number: 5
DI Record Publish Date: January 03, 2018