FDA UDI
In Commercial Distribution
🇺🇸 United States
Hokanson
DI: 00817065022386
·
Model: RD2™
·
D.E.HOKANSON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hokanson
- Primary DI
- 00817065022386
- Version / Model
- RD2™
- Catalog Number
- 03599
- Company Name
- D.E.HOKANSON, INC.
- Labeler DUNS
- 071829634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-31
- Public Version
- 4
- Public Version Date
- 2020-10-02
- Public Version Status
- Update
- Public Device Record Key
- e15b0637-443f-4f00-a5b8-2f753a49e461
Device Description
RAPID CUFF DEFLATOR - BAYONET VERSION - A single pneumatic valve accessory for interconnecting a cuff inflator to one or two blood pressure cuffs. The cuffs can be rapidly deflated completely with the valve of the pneumatic valve accessory, separately from the 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 |
|---|---|---|---|---|
| 62334 | Blood pressure cuff deflator | A non-powered device intended to interface between a blood pressure cuff inflator and a blood pressure cuff to allow manually-controlled and rapid venting/deflation of the cuff. It is typically a small unit with an internal valve and control (e.g., plunger). It is typically intended to be used during venous outflow measurements. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817065022386 | GS1 |
Customer Contacts
- Phone
- 800-999-8251
- [email protected]
- Phone
- 425-882-1689
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K842067 | 000 |