FDA UDI
In Commercial Distribution
🇺🇸 United States
XT Anesthesia Workstation (AWS)
DI: 00860006285012
·
Model: XT-AWS
·
Omnicell, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XT Anesthesia Workstation (AWS)
- Primary DI
- 00860006285012
- Version / Model
- XT-AWS
- Company Name
- Omnicell, Inc.
- Labeler DUNS
- 079417702
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-15
- Public Version
- 1
- Public Version Date
- 2021-02-23
- Public Version Status
- New
- Public Device Record Key
- 9836b183-bc64-4e45-a6a6-e8fbb5e4cc76
Device Description
The Omnicell XT Anesthesia Workstation (AWS) is an automated dispensing system intended for securing and managing medications used by anesthesia providers and pharmacy staff.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| BRY | Cabinet, Table And Tray, Anesthesia | Anesthesiology | 868.6100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34885 | Anaesthesia cabinet | A furniture-like device, typically designed as a small cupboard on wheels, used for the secure storage of anaesthetic equipment and drugs. It typically includes an appropriate working surface for anaesthetics, instruments, vials, or other small devices. It is usually constructed to prevent the build-up of static electrical charges. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860006285012 | GS1 |