FDA UDI
In Commercial Distribution
🇺🇸 United States
Salter Labs
DI: 00607411918100
·
Model: SO-1975
·
SALTER LABS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Salter Labs
- Primary DI
- 00607411918100
- Version / Model
- SO-1975
- Catalog Number
- 270.996
- Company Name
- SALTER LABS
- Labeler DUNS
- 022721133
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-30
- Public Version
- 4
- Public Version Date
- 2024-02-09
- Public Version Status
- Update
- Public Device Record Key
- 4b8e2e6c-9abe-45c9-9845-daecaa22ae09
Device Description
Nasal cannula, neonate Maximum Input Flow 7 L/min
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAT | CANNULA, NASAL, OXYGEN | Anesthesiology | 868.5340 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00607411918100 | GS1 | ||||
| Package | 10607411918107 | GS1 | BX | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)421-0024
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | neonate |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- N/A
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius