FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Zephyr Vascular Compression Device
DI: 10815614020743
·
Model: 9100-20
·
SEMLER TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Zephyr Vascular Compression Device
- Primary DI
- 10815614020743
- Version / Model
- 9100-20
- Catalog Number
- 190-0100-20
- Company Name
- SEMLER TECHNOLOGIES, INC.
- Labeler DUNS
- 042075700
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-17
- Public Version
- 5
- Public Version Date
- 2023-07-03
- Public Version Status
- Update
- Public Device Record Key
- 71719972-e597-4a26-a70f-4978845972fb
- Distribution End Date
- 2023-06-30
Device Description
The Zephyr Vascular Compression Device Model 9100-20 has a single easily inflatable compression balloon that is easily adjustable to help facilitate patent hemostasis in the radial artery. The Model 9100-20 provides the large strap which 11.8”/30cm long.
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
- No
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 |
|---|---|---|---|---|
| 58704 | Radial artery compression device | A device intended to provide compression for haemostasis to the puncture site on a patient having undergone radial artery catheterization, and can be used as an alternative to direct hand pressure. It typically consists of one or more pad/strap(s), which may also have a compression/decompression knob and a time indicator; it may be applied so that it does not compress the ulna artery or block venous return. It is typically used following coronary angiography/ventriculography or percutaneous transluminal coronary angioplasty (PTCA). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30815614020747 | GS1 | Bag | 10 | Not in Commercial Distribution | 2023-06-30 |
| Primary | 10815614020743 | GS1 | ||||
| Package | 20815614020740 | GS1 | Case | 50 | Not in Commercial Distribution | 2023-06-30 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151363 | 000 |