FDA UDI
In Commercial Distribution
🇺🇸 United States
PreludeSYNC DISTAL™
DI: 10884450574383
·
Model: B
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- PreludeSYNC DISTAL™
- Primary DI
- 10884450574383
- Version / Model
- B
- Catalog Number
- SDRB10AC
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-02-23
- Public Version
- 1
- Public Version Date
- 2024-03-04
- Public Version Status
- New
- Public Device Record Key
- 3788e87c-8815-4cc4-8df0-6d953a942427
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00884450574386 | GS1 | ||||
| Primary | 10884450574383 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size (Volume)-10 mL |