FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MediConnect
DI: 08592346756458
·
Model: MCN O2 G1 DSF DSF G
·
GCE, s.r.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MediConnect
- Primary DI
- 08592346756458
- Version / Model
- MCN O2 G1 DSF DSF G
- Catalog Number
- 0731001US
- Company Name
- GCE, s.r.o.
- Labeler DUNS
- 819753190
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-01
- Public Version
- 1
- Public Version Date
- 2023-02-09
- Public Version Status
- New
- Public Device Record Key
- 466ad86e-7a77-49cd-b10d-78debcfe647a
- Distribution End Date
- 2023-02-01
Device Description
Low-pressure hoses are intended for the transfer of medical gases or vacuum, and/or the connection of two medical products (e.g. a pressure regulator with an emergency ventilator).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66373 | Mixed-respiratory-gas low pressure hose | A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct a specific compressed medical gas mixture (e.g., helium/oxygen, nitrous oxide/oxygen mixture) from a specific terminal unit or cylinder to an appropriate respiratory/ventilatory medical device. The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is reinforced with, e.g., woven polyester or cotton and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08592346756458 | GS1 |