FDA UDI
In Commercial Distribution
🇺🇸 United States
Ultraview SL®
DI: 10841522106293
·
Model: Ultraview SL®
·
SPACELABS HEALTHCARE (WASHINGTON), INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ultraview SL®
- Primary DI
- 10841522106293
- Version / Model
- Ultraview SL®
- Catalog Number
- 91424-A
- Company Name
- SPACELABS HEALTHCARE (WASHINGTON), INC
- Labeler DUNS
- 145581588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-28
- Public Version
- 6
- Public Version Date
- 2023-10-26
- Public Version Status
- Update
- Public Device Record Key
- f455ca58-c9ac-433b-afd3-0d8d5fc734d7
Device Description
BASE UNIT, SVO2/SCVO2 MODULE,91424
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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37172 | Patient monitoring system module, intracardiac oximetry | A small unit designed to measure the ratio of oxyhaemoglobin (O2Hb) to reduced haemoglobin (RHb) and/or deoxyhaemoglobin (HHb) within the heart by comparing the absorption of red and infrared light in the blood [mixed venous oxygen saturation (SvO2)]. A fibreoptic probe is inserted into the pulmonary artery, often a Swan-Ganz catheter, to detect the SvO2 levels. It is designed to operate as part of a patient monitoring system enhancing the function of this parent device. The module automatically plugs into the parent device when placed into a standardized slot in the parent device which then operates as a mainframe computer displaying the SvO2 information measured by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841522106293 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K893867 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity