FDA UDI
In Commercial Distribution
🇺🇸 United States
Ohio
DI: 00628101540364
·
Model: HS-07U2-DFDFC4
·
OHIO MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ohio
- Primary DI
- 00628101540364
- Version / Model
- HS-07U2-DFDFC4
- Catalog Number
- HS-07U2-DFDFC4
- Company Name
- OHIO MEDICAL, LLC
- Labeler DUNS
- 005192885
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-09
- Public Version
- 1
- Public Version Date
- 2026-02-17
- Public Version Status
- New
- Public Device Record Key
- 70fc2fe7-dc3c-49c7-8792-7e8f14e60536
Device Description
7FT. HOSE ASSEMBLY DF*DF N2O COND
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 37936 | Nitrous oxide low pressure hose | A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed nitrous oxide (N2O) from an N2O terminal unit or N2O cylinder to a medical device that functions with N2O (e.g., ventilator, anaesthesia unit, analgesia unit, or other N2O dependent 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 | 00628101540364 | GS1 |
Customer Contacts
- Phone
- +1(847)855-6218
- [email protected]