Device
Salter Labs Patient Kit
Manufacturer
SALTER LABS
Model: SO-2169-0 Catalog: SO-2169-0 DI: 00607411973055 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-11 Current Version: 2026-05-19
Description
Salter Labs Patient Kit
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: daca7049-397d-4a1e-afd1-8e4de3a3036d
Distribution Status: In Commercial Distribution
DUNS Number: 022721133
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: Yes
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Pkg Type: Case
Item #1 - Device ID: 10607411973052
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 29
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00607411973055
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00607411973055
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 35201
Name: Nasal oxygen cannula, basic
Definition:
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.
FDA Product Codes
CAT
Cannula, Nasal, Oxygen
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value: -20
Storage Handling - Storage Handling High - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value: 50
Storage Handling - Storage Handling Type: Storage Environment Temperature