FDA UDI
In Commercial Distribution
🇺🇸 United States
Evacuation HoverJack
DI: 00816299010428
·
Model: HJ32EV-2
·
Hovertech International
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Evacuation HoverJack
- Primary DI
- 00816299010428
- Version / Model
- HJ32EV-2
- Catalog Number
- HJ32EV-2
- Company Name
- Hovertech International
- Labeler DUNS
- 942139841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9028c395-bc18-42c1-981c-03f7a2dabd66
Device Description
32" Evacuation HoverJack
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FNG | LIFT, PATIENT, AC-POWERED | General Hospital | 880.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40538 | Manual patient lifting belt/harness | A device used to assist healthcare professionals or attending persons to physically move and lift a patient or a person with a disability (e.g., from the floor to a bed). The device is typically made strong textile materials (e.g., nylon or canvas) consisting of belts/harnesses. The device will typically require two persons to safely perform the lift. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816299010428 | GS1 |
Customer Contacts
- Phone
- +1(800)471-2776 ext. 103
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041503 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 32 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 158 Degrees Fahrenheit