FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDADV
DI: 00819667020197
·
Model: M409
·
MEDAS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDADV
- Primary DI
- 00819667020197
- Version / Model
- M409
- Catalog Number
- M409
- Company Name
- MEDAS INC
- Labeler DUNS
- 080593067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-10
- Public Version
- 1
- Public Version Date
- 2018-05-11
- Public Version Status
- New
- Public Device Record Key
- 6d97ed70-05e2-4f89-83e4-2ac037fcdf73
Device Description
DISPOSABLE CO-AXIAL ANAESTHESIA BREATHING CIRCUIT, T PIECE CONNECTOR, ADULT 30MM, 60", 2 L LATEX FREE RESERVOIR BAG
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | Anesthesiology | 868.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62728 | Anaesthesia breathing circuit, single-use, sterile | A sterile assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anaesthesia unit/workstation to the patient, typically connecting the patient, a ventilator/ventilation bag, carbon dioxide (CO2) absorber, and a monitor. It typically includes both an inhalation and exhalation route and consists of breathing tubes, a ventilation and/or reservoir bag(s), a Y-piece, connectors/adaptors, and gas sampling ports. The absorber, a one-way directional valve, and adjustable pressure limiting (APL) valve are devices also typically employed in the circuit but may not be a part of this device. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819667020197 | GS1 |
Customer Contacts
- Phone
- +1(786)832-0459
- [email protected]