AccessGUDID - DEVICE: N/A (00607411102059)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: SO-2036-14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SO-2036-14
Company Name: SALTER LABS

Primary DI Number: 00607411102059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022721133 *Terms of Use

Device Description: ADULT DIVIDED CANNULA W/ 14' O2 LINE AND 14' CO2 LINE W/ MALE LUER-LOCK CONNECTOR

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:	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?
36307	Laser beam-blocking barrier	A dedicated device designed to provide protection, typically for healthcare personnel, from inadvertent laser radiation by attenuating, reflecting, and/or blocking laser energy. The device can be configured to cover a window, doorway or to partition an area of a room.	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 [?]
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 5 and 40 Degrees Celsius
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: beb818f0-6a8b-4df4-9cfc-223c46c68670
Public Version Date: March 21, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016