FDA UDI
In Commercial Distribution
🇺🇸 United States
Iradimed Pediatric Capnography Cannula
DI: 10889483295342
·
Model: 1842P
·
SALTER LABS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Iradimed Pediatric Capnography Cannula
- Primary DI
- 10889483295342
- Version / Model
- 1842P
- Company Name
- SALTER LABS
- Labeler DUNS
- 022721133
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-04
- Public Version
- 1
- Public Version Date
- 2025-08-12
- Public Version Status
- New
- Public Device Record Key
- b067fd63-baa3-4141-82d9-ff4fa45f968b
Device Description
Iradimed, Sampling Pediatric Capnography Cannula, Male Luer Style, 7' CO2, No O2
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36306 | Nasal oxygen cannula, carbon-dioxide-sampling | 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 simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30889483236349 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 10889483295342 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151421 | 000 |