FDA UDI
In Commercial Distribution
🇺🇸 United States
ARTERIAL WAND
DI: 00859821006698
·
Model: 3Fr x 5cm
·
ACCESS SCIENTIFIC, LLC
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ARTERIAL WAND
- Primary DI
- 00859821006698
- Version / Model
- 3Fr x 5cm
- Catalog Number
- 96001
- Company Name
- ACCESS SCIENTIFIC, LLC
- Labeler DUNS
- 079290879
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-11
- Public Version
- 1
- Public Version Date
- 2018-11-12
- Public Version Status
- New
- Public Device Record Key
- 20dd937d-639a-4b97-8d14-05129c601527
Device Description
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
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
- 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 |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
| DQY | Catheter, Percutaneous | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40601 | Peripheral vascular catheter | A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20859821006692 | GS1 | 12 | In Commercial Distribution | ||
| Package | 10859821006695 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00859821006698 | GS1 |
Customer Contacts
- Phone
- 1-858-259-8334
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181563 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 21 | Gauge | |
| Catheter Gauge | 3 | French | |
| Catheter Length | 5 | Centimeter |