FDA UDI
In Commercial Distribution
🇺🇸 United States
Claricuff™
DI: B593CSST2635HP0
·
Model: Tapmedic
·
Ningbo Albert Novosino Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Claricuff™
- Primary DI
- B593CSST2635HP0
- Version / Model
- Tapmedic
- Company Name
- Ningbo Albert Novosino Co.,Ltd.
- Labeler DUNS
- 543014978
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-22
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 3c901b89-c932-4f98-916b-596dc62d4480
- Distribution End Date
- 2028-03-22
Device Description
Claricuff™ Non-Invasive Blood Pressure Cuffs and Accessories
Device Characteristics
- Single Use
- Yes
- 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
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXQ | Blood Pressure Cuff | Cardiovascular | 870.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37326 | Blood pressure cuff, single-use | 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 typically wrapped around the upper arm of the patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B593CSST2635HP0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173044 | 000 |