FDA UDI
In Commercial Distribution
🇺🇸 United States
CompressAR StrongArm XL SuperComfort Stand
DI: 10815614020507
·
Model: 6000
·
SEMLER TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CompressAR StrongArm XL SuperComfort Stand
- Primary DI
- 10815614020507
- Version / Model
- 6000
- Catalog Number
- 160-0000-17
- 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
- 85760243-2c16-4958-bdf3-a8d93762bd8a
Device Description
The CompressAR StrongArm XL SuperComfort Stand is an extended length stand used with CompressAR SuperComfort Discs, to provide hemostasis of the femoral vascular access site following femoral artery catheterization procedures.
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 | 10815614020507 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040615 | 000 |