FDA UDI
In Commercial Distribution
🇺🇸 United States
144"Adult Circuit, Bi-Wye
DI: 00709078003288
·
Model: 9579
·
WESTMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 144"Adult Circuit, Bi-Wye
- Primary DI
- 00709078003288
- Version / Model
- 9579
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b0bb8838-b2da-46b1-8724-3708687c656f
Device Description
144" Adult EXP, GSE, Wye w/GSP, Large Mask, 2LF, GSL, suction tube
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 |
|---|---|---|---|---|
| 46232 | Anaesthesia face mask, single-use | A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10709078003285 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 00709078003288 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity