AccessGUDID - DEVICE: N/A (00607411101588)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 1616TLC™-7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1616TLC™-7
Company Name: SALTER LABS

Primary DI Number: 00607411101588
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022721133 *Terms of Use

Device Description: Nasal Cannula (adult) TLCannula™ with 7' (2.1 m) supply tube “micro” cannula for flows up to 3 LPM

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:	Yes
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?
35201	Nasal oxygen cannula, basic	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAT	CANNULA, NASAL, OXYGEN

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: N/A
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Adult

Device Record Status

Public Device Record Key: 2241dd0e-4d3b-4e4c-a063-e16eb8be5ca7
Public Version Date: March 22, 2022
Public Version Number: 3
DI Record Publish Date: November 30, 2016