FDA UDI
In Commercial Distribution
🇺🇸 United States
Merit Advance®
DI: 00884450008980
·
Model: 00884450008980
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Merit Advance®
- Primary DI
- 00884450008980
- Version / Model
- 00884450008980
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 54a6f683-7f89-4143-b38e-2bdc1548977f
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DRC | Trocar | Cardiovascular | 870.1390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34916 | Anaesthesia conduction catheter holder, sterile | A sterile device in the form of an adhesive backed pad with a locking mechanism that is used to secure an anaesthesia conduction catheter at the skin insertion site to prevent catheter migration. Also known as an epidural securement device. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884450008984 | GS1 | 4 | In Commercial Distribution | ||
| Package | 10884450008987 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00884450008980 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Gauge-19G | ||
| Device Size Text, specify | Accepts Guide Wire-0.035" (0.89 mm) | ||
| Device Size Text, specify | Length (cm)-5.0 cm |