FDA UDI
In Commercial Distribution
🇺🇸 United States
72"Adult Circuit, Bi-Wye
DI: 00709078002236
·
Model: 9567
·
WESTMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 72"Adult Circuit, Bi-Wye
- Primary DI
- 00709078002236
- Version / Model
- 9567
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-28
- Public Version
- 4
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 9295ecbf-1e12-4d97-a07e-b56082e24188
Device Description
72"Adult Circuit, Bi-Wye, plain elbow, tube hanger
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | Anesthesiology | 868.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37704 | Anaesthesia breathing circuit, single-use | An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10709078002233 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 00709078002236 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius