POWERWAND XL
- Primary DI
- 30859821006101
- Brand
- POWERWAND XL
- Company
- ICU MEDICAL, INC.
- Model
- 3Fr x 6cm
- Catalog number
- 94122
- Device description
- The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque
- Published
- 2017-02-28
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
accessscientific.comProduct Codes#
| Code | Name |
|---|---|
| DYB | Introducer, Catheter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K162322 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20859821006104 | Package | GS1 | 10 | In Commercial Distribution |
| 30859821006101 | Package | GS1 | 12 | In Commercial Distribution |
| 10859821006107 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20859821006104 | 20859821006104 |
| 30859821006101 | 30859821006101 |
| 10859821006107 | 10859821006107 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 3 | French |
| Length | 6 | Centimeter |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Temperature | 32 Degrees Fahrenheit | 104 Degrees Fahrenheit | |
| Special Storage Condition, Specify | 0 | 0 | Protect from direct contact with sun, water and humidity |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 1-858-259-8333 | cs@accessscientific.com |
Regulatory Flags#
- DUNS number
- 118380146
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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