AccessGUDID - DEVICE: Ventlab (10889483107805)

GUDID

Device Identifier (DI) Information

Brand Name: Ventlab
Version or Model: VP700
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: VP700
Company Name: VENTLAB, LLC

Primary DI Number: 10889483107805
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 038305402 *Terms of Use

Device Description: 19mm ID Adjustable PEEP Valve

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?
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
Special Storage Condition, Specify: General Warehouse. Do not get wet.

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 30 Millimeter
Lumen/Inner Diameter: 19 Millimeter

Device Record Status

Public Device Record Key: 0ee68367-ee73-40de-9b20-3b4e607abe90
Public Version Date: February 28, 2025
Public Version Number: 4
DI Record Publish Date: September 26, 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
20889483107802	20	10889483107805	2025-02-28	Not in Commercial Distribution	Box

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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-433-2797
Email: info@sun-med.com

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