FDA UDI
In Commercial Distribution
🇺🇸 United States
The Harris Products Group
DI: 00850005066217
·
Model: REG,301-50PS BARE
·
J. W. HARRIS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- The Harris Products Group
- Primary DI
- 00850005066217
- Version / Model
- REG,301-50PS BARE
- Catalog Number
- 3500636
- Company Name
- J. W. HARRIS CO., INC.
- Labeler DUNS
- 004233490
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-19
- Public Version
- 1
- Public Version Date
- 2020-05-27
- Public Version Status
- New
- Public Device Record Key
- b3a7691b-43e5-45a8-837b-429c8e40ef37
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | Anesthesiology | 868.2700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60944 | Medical air cylinder regulator | A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical air cylinder to lower high, variable gas pressure (e.g., 50 - 250 bar) to a lower, constant working pressure (typically 3 - 5 bar). It can be a single- or dual-stage regulator, usually of a piston or diaphragm design. It includes a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may include associated devices, usually a manometer(s), to display the available gas reserve of the air cylinder and the working pressure. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850005066217 | GS1 |