FDA UDI
In Commercial Distribution
🇺🇸 United States
Extra large D-ring Cuff for Telehealth Blood Pressure Monitor
DI: 00073796423124
·
Model: HEM-RXL31-B
·
Omron Healthcare, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Extra large D-ring Cuff for Telehealth Blood Pressure Monitor
- Primary DI
- 00073796423124
- Version / Model
- HEM-RXL31-B
- Catalog Number
- HEM-RXL31-B
- Company Name
- Omron Healthcare, Inc.
- Labeler DUNS
- 054318779
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-01
- Public Version
- 1
- Public Version Date
- 2022-08-09
- Public Version Status
- New
- Public Device Record Key
- 88d2412f-4e9b-4c6f-9f44-6bb438685e87
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 34978 | Blood pressure cuff, reusable | A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10073796423121 | GS1 | case | 10 | In Commercial Distribution | |
| Primary | 00073796423124 | GS1 |
Customer Contacts
- Phone
- 1-800-634-4350
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163235 | 000 |