FDA UDI
In Commercial Distribution
🇺🇸 United States
CompressAR Jumbo SuperComfort Disc
DI: 10815614020248
·
Model: 5305
·
SEMLER TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CompressAR Jumbo SuperComfort Disc
- Primary DI
- 10815614020248
- Version / Model
- 5305
- Catalog Number
- 150-0305-06
- 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
- 4
- Public Version Date
- 2023-07-04
- Public Version Status
- Update
- Public Device Record Key
- 94d4caf7-0b4b-44bf-9575-69b9e17eda89
Device Description
The CompressAR Jumbo SuperComfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The Model 5305 is a jumbo sized round disc with upturned edges and an elastomeric center (2.625" dia.).
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 47927 | Femoral artery compression system, manual, single-use | 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; it may in addition be used on brachial and radial arteries or after venipuncture. 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 may be used in conjunction with dressings/haemostatic agents (not included). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10815614020248 | GS1 | ||||
| Package | 20815614020245 | GS1 | Box | 12 | In Commercial Distribution | |
| Package | 30815614020242 | GS1 | Case | 12 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040615 | 000 |