FDA UDI
In Commercial Distribution
🇺🇸 United States
Quality Connect
DI: 04251411701833
·
Model: DIN-CO2-NIST-NIST-1,5
·
DEHAS Medical Systems GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Quality Connect
- Primary DI
- 04251411701833
- Version / Model
- DIN-CO2-NIST-NIST-1,5
- Catalog Number
- DIN-CO2-NIST-NIST1,5
- Company Name
- DEHAS Medical Systems GmbH
- Labeler DUNS
- 343728657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-16
- Public Version
- 3
- Public Version Date
- 2024-05-16
- Public Version Status
- Update
- Public Device Record Key
- e8d2ab46-ed46-4bf6-977a-a5a1f7e4cbc7
Device Description
Connection hose DIN, CO2, NIST-screwing to NIST-screwing, ISO color, 1.50 m long
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 66374 | Carbon dioxide low pressure hose | A length of reinforced colour-coded flexible tubing produced according to ISO5359 and intended to conduct compressed carbon dioxide (CO2) from a CO2 terminal unit or CO2 cylinder to a medical device that functions with CO2 (e.g., ventilator, insufflation system). 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 | 04251411701833 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- -15°Celsius to +50°Celsius