AccessGUDID - DEVICE: Disposable PEEP 20 valve (05707480030767)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable PEEP 20 valve
Version or Model: 199003100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 199003100
Company Name: Ambu A/S

Primary DI Number: 05707480030767
Issuing Agency: GS1
Commercial Distribution End Date: February 10, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: Ambu PEEP valve 20, disposable with 30-18 Adapter 100 pcs./set

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
46823	PEEP valve, single-use	A non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYE	Attachment, breathing, positive end expiratory pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7daa5402-ba1d-4ccb-b898-39240298ef88
Public Version Date: February 10, 2022
Public Version Number: 3
DI Record Publish Date: January 07, 2016