FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00840682104135
·
Model: E-sCAiOE-00
·
GE Healthcare Finland Oy
Product Codes
10
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00840682104135
- Version / Model
- E-sCAiOE-00
- Company Name
- GE Healthcare Finland Oy
- Labeler DUNS
- 401966697
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-07
- Public Version
- 1
- Public Version Date
- 2022-03-15
- Public Version Status
- New
- Public Device Record Key
- 2bc47552-ab64-4fd1-8946-9e3c74085b5a
Device Description
E-SCAIOE-00, MODULE ASSEMBLY
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) | Anesthesiology | 868.1500 | 2 |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) | Anesthesiology | 868.1500 | 2 |
| NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) | Anesthesiology | 868.1500 | 2 |
| CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) | Anesthesiology | 868.1620 | 2 |
| BZK | Spirometer, monitoring (w/wo alarm) | Anesthesiology | 868.1850 | 2 |
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) | Anesthesiology | 868.2600 | 2 |
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) | Anesthesiology | 868.1700 | 2 |
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) | Anesthesiology | 868.1500 | 2 |
| BZL | COMPUTER, OXYGEN-UPTAKE | Anesthesiology | 868.1730 | 2 |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37061 | Patient monitoring system module, multiple-gas | A small unit dedicated to the measurement of various gas concentrations, e.g., anaesthetic agents, oxygen (O2), carbon dioxide (CO2), in inspired and expired air 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 system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot and the parent device then operates as a mainframe computer displaying the parameters measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840682104135 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211171 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 66 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 98 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 60 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal