FDA UDI
In Commercial Distribution
🇺🇸 United States
Hokanson
DI: 00817065021273
·
Model: E20 Foot switch
·
D.E.HOKANSON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hokanson
- Primary DI
- 00817065021273
- Version / Model
- E20 Foot switch
- Catalog Number
- 01800
- Company Name
- D.E.HOKANSON, INC.
- Labeler DUNS
- 071829634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 4
- Public Version Date
- 2020-10-05
- Public Version Status
- Update
- Public Device Record Key
- f4a965f4-4724-4077-87a8-9ee02d2f2f8d
Device Description
A manual foot switch used to activate the inflation and deflation of a cuff connected to the E20 Rapid Cuff Inflator.
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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36336 | Foot-switch, electrical | An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817065021273 | GS1 |
Customer Contacts
- Phone
- 800-999-8251
- [email protected]
- Phone
- 425-882-1689
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905367 | 000 |