FDA UDI
In Commercial Distribution
🇺🇸 United States
Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit
DI: 00636207315243
·
Model: VM72DLNEX
·
Global Life Sciences Solutions USA LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit
- Primary DI
- 00636207315243
- Version / Model
- VM72DLNEX
- Catalog Number
- VM72DLNEX
- Company Name
- Global Life Sciences Solutions USA LLC
- Labeler DUNS
- 011658242
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-29
- Public Version
- 5
- Public Version Date
- 2024-02-29
- Public Version Status
- Update
- Public Device Record Key
- cf44d38b-6fbf-4468-be82-aae077ee5b07
Device Description
Adult 72" Nonexpandable Dual Limb Circuit, 0.060" ID CO2 Gas Sampling Line, and 3 Liter Non-Latex Breathing Bag.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| CAH | Filter, bacterial, breathing-circuit | Anesthesiology | 868.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37021 | Anaesthesia breathing circuit, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30636207315244 | GS1 | case | 20 | In Commercial Distribution | |
| Primary | 00636207315243 | GS1 |
Customer Contacts
- Phone
- +1(800)645-6578 ext. 5164843600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013093 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 72 | Inch |