FDA UDI
In Commercial Distribution
🇺🇸 United States
PICC WAND
DI: 10859821006152
·
Model: 6Fr
·
ACCESS SCIENTIFIC, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PICC WAND
- Primary DI
- 10859821006152
- Version / Model
- 6Fr
- Catalog Number
- 91012
- Company Name
- ACCESS SCIENTIFIC, LLC
- Labeler DUNS
- 079290879
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 4
- Public Version Date
- 2019-06-07
- Public Version Status
- Update
- Public Device Record Key
- 4e8a7088-c664-48bf-bb39-8042412b3775
Device Description
The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
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 |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30859821006156 | GS1 | Overpack | 18 | In Commercial Distribution | |
| Package | 20859821006159 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 10859821006152 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111138 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7 | Centimeter | |
| Catheter Gauge | 6 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from direct contact with sun, water and humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit