FDA UDI
In Commercial Distribution
🇺🇸 United States
DISPO-MED
DI: 09555866300869
·
Model: DM-7100/CO-10FTST
·
DISPO-MED (MALAYSIA) SDN. BHD.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- DISPO-MED
- Primary DI
- 09555866300869
- Version / Model
- DM-7100/CO-10FTST
- Company Name
- DISPO-MED (MALAYSIA) SDN. BHD.
- Labeler DUNS
- 597426907
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-01
- Public Version
- 1
- Public Version Date
- 2025-08-11
- Public Version Status
- New
- Public Device Record Key
- 044615c8-5006-4e72-a38f-9e3361676d3b
Device Description
The Gas Sampling lines are intended to interface with the patient via nasal canula, nares connector, or standard sampling port connectors to the expired gas monitor.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 | 09555866300876 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 09555866300869 | GS1 | ||||
| Package | 09555866301224 | GS1 | 100 | In Commercial Distribution | ||
| Package | 09555866301231 | GS1 | 800 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143127 | 000 |