FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AnaPod
DI: 00709078001185
·
Model: A4070
·
WESTMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AnaPod
- Primary DI
- 00709078001185
- Version / Model
- A4070
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-14
- Public Version
- 4
- Public Version Date
- 2022-09-14
- Public Version Status
- Update
- Public Device Record Key
- f1192173-a2e0-43a0-9818-dca967f8a1e9
- Distribution End Date
- 2022-09-13
Device Description
Replacement Cable
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | 868.5450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35872 | Airway temperature monitoring system | An assembly of devices typically used bedside to continuously measure the temperature at a specific point along a ventilation airway (e.g., inspiratory limb, Y-piece). It typically includes a temperature sensor, a transducer, a cable, and an electronic unit with a display and alarms (audible and/or visual). The system provides real-time information on the temperature of the gases supplied to patients under assisted ventilation, particularly when a heated humidifier is incorporated into the inspiratory line of a patient's breathing circuit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10709078001182 | GS1 | 1 | Not in Commercial Distribution | 2022-09-13 | |
| Primary | 00709078001185 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K870173 | 000 |