AccessGUDID - DEVICE: Puritan Bennett (20884521134819)

GUDID

Device Identifier (DI) Information

Brand Name: Puritan Bennett
Version or Model: Y-102616-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: Y-102616-00
Company Name: Covidien LP

Primary DI Number: 20884521134819
Issuing Agency: GS1
Commercial Distribution End Date: August 14, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: CPAP Interface with Nasal Cushion Assembly,Standard

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?
35176	Anaesthesia face mask, reusable	A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002001	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
Special Storage Condition, Specify: ;
Handling Environment Temperature: between 41 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dcc6382b-d987-43df-b507-fa0bd2feae8b
Public Version Date: June 13, 2025
Public Version Number: 7
DI Record Publish Date: September 24, 2016