AccessGUDID - DEVICE: Ventlab (10889483095157)

GUDID

Device Identifier (DI) Information

Brand Name: Ventlab
Version or Model: HCSA4568
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VENTLAB, LLC

Primary DI Number: 10889483095157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038305402 *Terms of Use

Device Description: Cannula, CO2 Sampling, Adult, 7' O2, 7' CO2

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?
17614	Exhaled-gas oesophageal intubation detector	A device designed to verify proper endotracheal (ET) tube placement by detecting/assessing exhaled carbon dioxide (CO2) during airway management to confirm correct intubation for appropriate ventilation; it may additionally be intended to confirm placement/ventilation when using a laryngeal mask airway and/or face mask. It is intended to be connected to the intubation device and/or ventilator breathing circuit (e.g., the T-piece connector or hose). It typically functions through colorimetric CO2 detection using a chemical reaction based and/or paper indicator that changes colour based on the approximate CO2 concentration. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063813	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: General Warehouse. Do not get wet.

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 22 Millimeter
Length: 7 Feet

Device Record Status

Public Device Record Key: 47e1faa6-072d-40a8-9119-58a356decc8b
Public Version Date: May 03, 2024
Public Version Number: 4
DI Record Publish Date: October 11, 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
20889483095154	1	10889483095157		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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