FDA UDI
In Commercial Distribution
🇺🇸 United States
ZEOS
DI: 00812231031582
·
Model: 84-28-0522
·
SANTA BARBARA IMAGING SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZEOS
- Primary DI
- 00812231031582
- Version / Model
- 84-28-0522
- Catalog Number
- 84-28-0522
- Company Name
- SANTA BARBARA IMAGING SYSTEMS, INC.
- Labeler DUNS
- 065016344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-03
- Public Version
- 1
- Public Version Date
- 2019-01-03
- Public Version Status
- New
- Public Device Record Key
- 2b2c4b3d-f608-48e6-8933-ef2553734987
Device Description
ZEOS CART CO2 BOTTLE HOLDER
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KRI | Accessory Equipment, Cardiopulmonary Bypass | Cardiovascular | 870.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41756 | Gas cylinder holder | A device designed to hold and secure a single medical gas cylinder of compressed medical gas which is to be used in medical treatment/therapy. The usual gases are, [e.g., oxygen (O2), air, or nitrous oxide (N2O)]. It is used to secure the cylinder both during transport and typically whilst the gas is being used. The device is typically constructed of metal and may be mounted to a medical device service rail system, a bed under transport, or other medical devices requiring medical gas to be present. It is configured to meet the size of the cylinder, typically those of small dimensions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812231031582 | GS1 |
Customer Contacts
- Phone
- 805-770-2110
- [email protected]