AccessGUDID - DEVICE: AF531 (00606959008809)

GUDID

Device Identifier (DI) Information

Brand Name: AF531
Version or Model: AF531 MASK EE, LEAK 2 with 4 PT Headgear, SU, Medium, CN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1119099
Company Name: Respironics, Inc.

Primary DI Number: 00606959008809
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: AF531 Mask with Entrainment Elbow, Leak 2, 4 Point Headgear, Single, China, Medium

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":	Yes
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?
57813	CPAP/BPAP face mask, single-use	A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101130	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
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b5370477-1684-4c46-b3a4-c4b05da6fe98
Public Version Date: February 01, 2021
Public Version Number: 5
DI Record Publish Date: February 12, 2016