FDA UDI
In Commercial Distribution
🇺🇸 United States
EasyShift
DI: 00860004936848
·
Model: EAS-36-Z
·
Seneca Devices, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EasyShift
- Primary DI
- 00860004936848
- Version / Model
- EAS-36-Z
- Company Name
- Seneca Devices, Inc.
- Labeler DUNS
- 117658378
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-12
- Public Version
- 1
- Public Version Date
- 2024-01-22
- Public Version Status
- New
- Public Device Record Key
- 01a96e54-d102-4b1b-ae3a-ee3b4f3648a0
Device Description
EasyShift Repositioning System V3 for 36-inch wide mattress
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
- 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 |
|---|---|---|---|---|
| FNK | Bed, Hydraulic, Adjustable Hospital | General Hospital | 880.5110 | 1 |
| IKZ | Bed, Patient Rotation, Powered | Physical Medicine | 890.5225 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43268 | Bed mattress support platform, hydraulic | A hydraulically-powered medical bed structure that supports a medical bed patient surface (e.g., a mattress) and that can articulate and/or change its surface to facilitate various therapeutic, diagnostic, and convenience positions. It is typically a flat structure made of a metal frame that operates in response to hand and foot controls. | No | Active |
| 66264 | Alternating-pressure bed mattress system remote control | A hand-operated electronic device designed to functionally connect to an electrically-powered, alternating-pressure bed mattress system to control its operation (e.g., pressure, inflation/deflation). It may connect to the mattress system via an electrical cable or operate wirelessly. It is intended to be operated by the healthcare provider. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860004936848 | GS1 |