FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PressureMate Compression Assist Device
DI: 10815614020057
·
Model: 3200
·
SEMLER TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PressureMate Compression Assist Device
- Primary DI
- 10815614020057
- Version / Model
- 3200
- Catalog Number
- 130-0200-00
- Company Name
- SEMLER TECHNOLOGIES, INC.
- Labeler DUNS
- 042075700
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 7
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 590baf4c-179e-4dd2-b223-72e5018da2fe
- Distribution End Date
- 2022-11-30
Device Description
The PressureMate Compression Assist Device is designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure with PressureMate in much the same way that they would when applying manual pressure. PressureMate is comprised of a non-sterile, reusable handle and a sterile, disposable SuperComfort Disc (Model 5303 or 5305) to aid in the practice of manual compression. The Model 3200 is of 12 oz. weighted aluminum construction.
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
- 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
- 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 | 10815614020057 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090286 | 000 |