FDA UDI
In Commercial Distribution
🇺🇸 United States
Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit
DI: 00709078004490
·
Model: A9241
·
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
- 00709078004490
- Version / Model
- A9241
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-16
- Public Version
- 3
- Public Version Date
- 2019-12-24
- Public Version Status
- Update
- Public Device Record Key
- 89940c60-7ea8-4f53-aeca-ddbb0a4f66f7
Device Description
Adult Heated Humidified Circuit, expandable up to 96"
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 |
|---|---|---|---|---|
| 60966 | Respiratory gas heating wire, adult | A non-sterile device intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory humidifier (from which it draws its power) to maintain the temperature of inspiratory gasses during ventilation of an adult patient. It typically consists of a compact heating unit and a length of heated wire which is integrated within the lumen of an adult breathing circuit tube. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10709078004497 | GS1 | 18 | In Commercial Distribution | ||
| Primary | 00709078004490 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K904538 | 000 |