FDA UDI
In Commercial Distribution
🇺🇸 United States
Hokanson
DI: 00817065021266
·
Model: E20 3 Second Timer
·
D.E.HOKANSON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hokanson
- Primary DI
- 00817065021266
- Version / Model
- E20 3 Second Timer
- Catalog Number
- 01752
- Company Name
- D.E.HOKANSON, INC.
- Labeler DUNS
- 071829634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2020-10-05
- Public Version Status
- Update
- Public Device Record Key
- cf099b0d-fae6-4760-b083-1e40f6640d87
Device Description
A battery powered remote timer used by a clinician to inflate and automatically deflate the connected 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
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62330 | Blood pressure cuff inflation timer | A small electronic unit intended to be connected to an electronic blood pressure cuff inflator (e.g., rapid inflation controller) to control the length of time the cuff remains inflated. It includes controls and is intended to send electrical signals to control the parent device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817065021266 | GS1 |
Customer Contacts
- Phone
- 800-999-8251
- [email protected]
- Phone
- 425-882-1689
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905367 | 000 |