FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Disposable Anesthesia Breathing Circuits
DI: 00709078009495
·
Model: 8095
·
WESTMED, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable Anesthesia Breathing Circuits
- Primary DI
- 00709078009495
- Version / Model
- 8095
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-30
- Public Version
- 4
- Public Version Date
- 2023-08-11
- Public Version Status
- Update
- Public Device Record Key
- 7ffb1776-9967-4de8-b102-35a53ad67650
- Distribution End Date
- 2023-08-11
Device Description
96" Expandable Adult Anesthesia Circuit, Parallel Wye W/GSP, GSE, 900 Series Large Adult Mask, (2) Bacterial Gilters, 3L Not Made With Latex Breathing Bag, 10' x 0.060 ID mm GSL
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OFP | Anesthesia Breathing Circuit Kit (Adult & Pediatric) | Anesthesiology | 868.5240 | 1 |
| 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 | 10709078009492 | GS1 | Case | 20 | Not in Commercial Distribution | 2023-08-11 |
| Primary | 00709078009495 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922492 | 000 |