FDA UDI
In Commercial Distribution
🇺🇸 United States
22MM SMOOTHBORE BILEVEL B/S WITH MON LINE AND SWIVEL CO2 LEAK PORT. 1.6M
DI: 05030267070534
·
Model: 5805000
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 22MM SMOOTHBORE BILEVEL B/S WITH MON LINE AND SWIVEL CO2 LEAK PORT. 1.6M
- Primary DI
- 05030267070534
- Version / Model
- 5805000
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-10
- Public Version
- 1
- Public Version Date
- 2022-11-18
- Public Version Status
- New
- Public Device Record Key
- 0aa2a907-81fc-48a7-9475-0d5eabc2c3a3
Device Description
22MM SMOOTHBORE BILEVEL BREATHING SYSTEM WITH MONITORING LINE AND SWIVEL CO2 LEAK PORT. 1.6M
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | Anesthesiology | 868.5240 | 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 |
|---|---|---|---|---|---|---|
| Package | 05030267153558 | GS1 | 35 | In Commercial Distribution | ||
| Primary | 05030267070534 | GS1 |
Customer Contacts
- Phone
- 3154512900
- [email protected]