FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00818834026147
·
Model: 301-0318LTFM-PED
·
TRI-ANIM HEALTH SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00818834026147
- Version / Model
- 301-0318LTFM-PED
- Catalog Number
- 301-0318LTFM-PED
- Company Name
- TRI-ANIM HEALTH SERVICES, INC.
- Labeler DUNS
- 010712461
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-01
- Public Version
- 2
- Public Version Date
- 2021-01-14
- Public Version Status
- Update
- Public Device Record Key
- cb7bd0dc-0513-4763-ad0c-a754b2b17b3e
- Distribution End Date
- 2020-12-18
Device Description
Pediatric Procedural Oxygen Mask with High Concentration & CO2 Monitoring (Male to Female)
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYG | MASK, OXYGEN | Anesthesiology | 868.5580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62179 | Capnography oxygen mask | A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver oxygen (O2) to a patient's airway, and to sample exhaled respiratory gases for monitoring the patient’s ventilatory status. It includes exhaled air sampling tubing for connection to a carbon dioxide monitor (capnograph), or physiology-monitoring sedation/anaesthesia system, for the measurement of end-tidal carbon dioxide (EtCO2) in expiratory gases; it is typically used during anaesthesia/sedation or bedside monitoring. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00818834026154 | GS1 | BX | 30 | Not in Commercial Distribution | 2020-12-18 |
| Primary | 00818834026147 | GS1 |