FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ETHICON
DI: 10705031228139
·
Model: EVRC67
·
ETHICON INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ETHICON
- Primary DI
- 10705031228139
- Version / Model
- EVRC67
- Catalog Number
- EVRC67
- Company Name
- ETHICON INC.
- Labeler DUNS
- 002144145
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-23
- Public Version
- 4
- Public Version Date
- 2023-03-16
- Public Version Status
- Update
- Public Device Record Key
- cbfef3b7-0728-4615-bb32-51d674d43af0
- Distribution End Date
- 2023-03-15
Device Description
CO2 Pressure Regulator
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 |
|---|---|---|---|---|
| 47860 | Surgical air pipeline regulator | A reduction valve designed to lower high and variable gas pressure in a pipeline intended for surgical applications (e.g., to drive surgical power tools) to a lower and constant working pressure, typically 3 - 12 bar. It consists of a housing containing a single- or dual-stage regulator used to regulate the surgical air, connectors (these may be permanent or quick connectors), and a pressure gauge; it may include an integral filter to remove possible contaminants, sometimes with a glass bowl for the collection of oil deposits and for observation. It is typically made of metal and synthetic polymer materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705031228139 | GS1 |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]