FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Microstream
DI: 10884521551473
·
Model: CS08658-01
·
ORIDION MEDICAL 1987 LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Microstream
- Primary DI
- 10884521551473
- Version / Model
- CS08658-01
- Company Name
- ORIDION MEDICAL 1987 LTD.
- Labeler DUNS
- 600111512
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 5
- Public Version Date
- 2024-03-01
- Public Version Status
- Update
- Public Device Record Key
- c625dad2-9bc1-40e2-afb4-62f77b4782c8
- Distribution End Date
- 2024-02-27
Device Description
CAPNOSTREAM 20P (INTL) N W/PRINTER
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
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36552 | Patient monitoring system module, carbon dioxide | A small unit dedicated to the measurement of carbon dioxide (CO2) content of expired gas obtained through a sampling tube connected to a main respiratory channel (mainstream) or a side-channel (sidestream) of a breathing circuit. It is designed to operate as part of a patient monitoring system enhancing the function of this (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or in a connected module rack. The parent device operates as a mainframe computer displaying the CO2 parameter/information measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884521551473 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- This side up;Keep dry;Fragile