FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxy2Mask O2/EtCO2
DI: 10620974003172
·
Model: OM-2125-14SLM
·
Southmedic Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Oxy2Mask O2/EtCO2
- Primary DI
- 10620974003172
- Version / Model
- OM-2125-14SLM
- Catalog Number
- OM-2125-14SLM
- Company Name
- Southmedic Incorporated
- Labeler DUNS
- 246848147
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2023-12-01
- Public Version
- 1
- Public Version Date
- 2023-12-11
- Public Version Status
- New
- Public Device Record Key
- 6bb94b34-174a-4c02-8114-9def1e40117d
Device Description
Oxy2Mask O2/EtCO2 Adult
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
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61834 | Breathing circuit gas-sampling/monitoring set | A collection of non-sterile devices intended to be integrated within a breathing circuit to enable interface of gases between the breathing circuit and a respiratory monitoring device for sampling the patient's expired gas for measurements of pressure, flow and/or gas analysis [e.g., end-tidal carbon dioxide (EtCO2) concentration]. It includes both a tube/mask breathing circuit connector with sampling ports (sometimes referred to as a spirometry sensor) and gas-sampling/monitoring respiratory tubing; no electronic devices are included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00620974003175 | GS1 | ||||
| Primary | 10620974003172 | GS1 |
Customer Contacts
- Phone
- +1(705)726-9383
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222511 | 000 |