FDA UDI
In Commercial Distribution
🇺🇸 United States
Spacelabs
DI: 10841522113109
·
Model: Multigas Module
·
SPACELABS HEALTHCARE (WASHINGTON), INC
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Spacelabs
- Primary DI
- 10841522113109
- Version / Model
- Multigas Module
- Catalog Number
- 92518
- Company Name
- SPACELABS HEALTHCARE (WASHINGTON), INC
- Labeler DUNS
- 145581588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-30
- Public Version
- 6
- Public Version Date
- 2023-10-26
- Public Version Status
- Update
- Public Device Record Key
- f60161c8-0bd6-471a-a768-313f8da74ef9
Device Description
MULTIGAS MODULE,92518
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
- 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 |
|---|---|---|---|---|
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) | Anesthesiology | 868.1700 | 2 |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Anesthesiology | 868.1400 | 2 |
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) | Anesthesiology | 868.1500 | 2 |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) | Anesthesiology | 868.1500 | 2 |
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) | Anesthesiology | 868.1500 | 2 |
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE | Anesthesiology | 868.1720 | 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 |
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 | 10841522113109 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112173 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius