FDA UDI
In Commercial Distribution
🇺🇸 United States
ExpressAR Mobile Compression Device
DI: 10815614020644
·
Model: 6225
·
SEMLER TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ExpressAR Mobile Compression Device
- Primary DI
- 10815614020644
- Version / Model
- 6225
- Catalog Number
- 160-2025-00
- Company Name
- SEMLER TECHNOLOGIES, INC.
- Labeler DUNS
- 042075700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 7011074a-0492-4f0a-b340-665eb4b69e44
Device Description
The ExpressAR Mobile Compression Device is a durable, reusable precision instrument that can be cleaned for reuse. When deploying ExpressAR, a sterile, disposable Disc and a non-sterile disposable Belt are attached to the device. The Disc and Belt come packaged as an ExpressAR Belt Kit, available with different sizes of Discs.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DXC | Clamp, Vascular | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46367 | Femoral artery compression system, manual, reusable | A noninvasive, non-powered device intended to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization, typically as an alternative to direct hand pressure. The compressing portion could be one of a variety of designs (e.g., disc affixed to a handle, ball, dome or roller, manually-inflatable bulb) and is typically held in place with a frame, bandage, or straps secured around the patient's hips/thigh. It is typically used following coronary angiography/ventriculography and PTCA; it may in addition be used on brachial and radial arteries or after venipuncture. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10815614020644 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970027 | 000 |