FDA UDI
In Commercial Distribution
🇺🇸 United States
Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit
DI: 00709078005466
·
Model: A9242
·
WESTMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit
- Primary DI
- 00709078005466
- Version / Model
- A9242
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-25
- Public Version
- 3
- Public Version Date
- 2021-03-10
- Public Version Status
- Update
- Public Device Record Key
- 768ffe7d-be05-416e-be4f-71533bf76ac2
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | Anesthesiology | 868.5270 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60928 | Laparoscopy carbon dioxide gas/refillable cylinder | Compressed medical carbon dioxide (CO2) in a dedicated refillable container intended to be used for laparoscopic insufflation. The cylinder is filled with CO2 when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and is graded according to size (capacity) and colour-coded to denote CO2 content. It is typically made of steel and must be used together with a pressure regulator in order to release the CO2 at the correct working pressure. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10709078005463 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00709078005466 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K904538 | 000 |