FDA UDI
In Commercial Distribution
🇺🇸 United States
EasyShift
DI: 00860004936817
·
Model: EAS-42-Z
·
Seneca Devices, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EasyShift
- Primary DI
- 00860004936817
- Version / Model
- EAS-42-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
- b18f338a-997e-4b97-9335-674754af5dee
Device Description
EasyShift Repositioning System V3 for 42" wide mattress, compatible with EasyShift Zipper Sheet
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 |
| 66260 | Intensive-care patient transport system, ventilatory support, neonatal | A mobile (on wheels) assembly of devices intended to be used to transport a neonatal patient (e.g., between healthcare facilities) with the in-transit provision of high-level critical care, especially ventilatory support (but not extracorporeal life support). It includes a neonatal incubator, ventilatory equipment (e.g., ventilator, nitric oxide delivery unit), infusion equipment [e.g., syringe driver(s), infusion pump], and patient monitors, mounted upon a patient trolley/stretcher; emergency airway clearing/resuscitation equipment may also be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860004936817 | GS1 |