AccessGUDID - DEVICE: Reusable PEEP 10 valve (05707480030668)

GUDID

Device Identifier (DI) Information

Brand Name: Reusable PEEP 10 valve
Version or Model: A137001000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A137001000
Company Name: Ambu A/S

Primary DI Number: 05707480030668
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: PEEP 10 valve

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
14337	PEEP valve, reusable	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 reusable 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
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 40 Gram
Length: 65 Millimeter
Outer Diameter: 45 Millimeter

Device Record Status

Public Device Record Key: fbda0cdb-9f81-4226-b2e1-f42fb324f2df
Public Version Date: April 29, 2024
Public Version Number: 3
DI Record Publish Date: January 07, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05707480015429	40	05707480030668		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +14107686464
Email: Purchase_orders@ambuUSA.com

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