FDA UDI
In Commercial Distribution
🇺🇸 United States
Resp-O2 Oxygen CO2 Elongated Mask and CO2 Sampling Line
DI: 00840117316102
·
Model: 33080
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Resp-O2 Oxygen CO2 Elongated Mask and CO2 Sampling Line
- Primary DI
- 00840117316102
- Version / Model
- 33080
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 1
- Public Version Date
- 2021-04-30
- Public Version Status
- New
- Public Device Record Key
- b275e2ff-3aaf-44cf-924d-5f4345a67931
Device Description
Resp-O2 Oxygen CO2 Elongated Adult Mask, CO2 Sampling Line w/ Filter, 7' (2.1m) Oxygen Tube; Male/Male Connector
Device Characteristics
- Single Use
- Yes
- 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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62698 | Capnography sampling adaptor | A non-sterile device intended to enhance the capture of exhaled end-tidal carbon dioxide (EtCO2) for evaluation of a patient's ventilatory, circulatory, or metabolic status, typically during the administration of anaesthesia. It is an adhesive, dome-like adaptor with connecting ports designed to function as an interface between an in situ airway device (e.g., oropharyngeal airway, face mask, nasal oxygen cannula) and respiratory sampling tubing connected to a carbon dioxide monitor (capnograph). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840117316027 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 00840117316102 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143150 | 000 |