FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SEDASYS
DI: 10705036010210
·
Model: SEDPSU01
·
ETHICON ENDO-SURGERY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SEDASYS
- Primary DI
- 10705036010210
- Version / Model
- SEDPSU01
- Catalog Number
- SEDPSU01
- Company Name
- ETHICON ENDO-SURGERY, INC.
- Labeler DUNS
- 123407392
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-17
- Public Version
- 3
- Public Version Date
- 2023-01-10
- Public Version Status
- Update
- Public Device Record Key
- 8be2ab8a-9d3b-4fac-a33f-c19309287f31
- Distribution End Date
- 2017-08-30
Device Description
SEDASYS POWER SUPPLY UNIT
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
- 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 |
|---|---|---|---|---|
| PDR | Computer-assisted personalized sedation system | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46924 | Intraprocedural physiologic-monitoring sedation system | An assembly of devices designed to monitor patient physiology while delivering a sedative agent intravenously during a diagnostic or surgical procedure (e.g., endoscopy, minor plastic surgery, cardiovascular procedure). It is a computer-assisted personalized sedation (CAPS) system that typically consists of physiologic/responsiveness monitors [e.g., for blood pressure, oxygen (O2) saturation, capnometry], an infusion pump, an O2 delivery module, alarms, controls, and a computer with software that integrates the components to react to the patient's physiology for precisely controlled sedation. It may contain batteries to facilitate use during transport (e.g., from bedside to procedure room). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705036010210 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity