FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Uni-lim Coaxial Circuit
DI: 00709078008030
·
Model: 9615
·
WESTMED, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Uni-lim Coaxial Circuit
- Primary DI
- 00709078008030
- Version / Model
- 9615
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-18
- Public Version
- 5
- Public Version Date
- 2023-08-04
- Public Version Status
- Update
- Public Device Record Key
- 2edbfcd2-aeb2-45eb-af95-80fdddfe8fca
- Distribution End Date
- 2023-08-04
Device Description
Anesthesia Circuit, Adult, Uni-lim, 60" Coaxial, w/24" flex expiatory lead, Inner Elbow w/GSP, In-Line Mini HMEF, Large adult mask with 10' suction tubing, 3L not made with latex bag, 10' x .050" ID M/M GSL, non vented non sterile yankauer
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00709078008030 | GS1 | ||||
| Package | 10709078008037 | GS1 | 10 | Not in Commercial Distribution | 2023-08-04 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922492 | 000 |