FDA UDI
In Commercial Distribution
🇺🇸 United States
KIT DISPOSABLE RESPIRATORY CIRCUIT
DI: 07898671250168
·
Model: 1707816
·
MAGNAMED TECNOLOGIA MEDICA SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- KIT DISPOSABLE RESPIRATORY CIRCUIT
- Primary DI
- 07898671250168
- Version / Model
- 1707816
- Catalog Number
- 1707816
- Company Name
- MAGNAMED TECNOLOGIA MEDICA SA
- Labeler DUNS
- 944224603
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-24
- Public Version
- 2
- Public Version Date
- 2025-05-29
- Public Version Status
- Update
- Public Device Record Key
- 1c644231-d410-4d99-8de4-161b2758fe03
Device Description
DUAL LIMB BREATHING CIRCUIT WITH UNIVERSAL FLOW SENSOR, FLOW SENSOR LINE, EXHALATION VALVE, DIAPHRAGM, AND HME FILTER FOR USE WITH OXYMAG, 1.5M, SINGLE-USE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | Anesthesiology | 868.5975 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37706 | Ventilator breathing circuit, single-use | An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898671250168 | GS1 |
Customer Contacts
- Phone
- +1 (954) 658-2689
- [email protected]