FDA UDI
In Commercial Distribution
🇺🇸 United States
PowerGlide ST
DI: 00801741226861
·
Model: PCK00013
·
Bard Access Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PowerGlide ST
- Primary DI
- 00801741226861
- Version / Model
- PCK00013
- Catalog Number
- PCK00013
- Company Name
- Bard Access Systems, Inc.
- Labeler DUNS
- 044611812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-05
- Public Version
- 1
- Public Version Date
- 2023-07-13
- Public Version Status
- New
- Public Device Record Key
- ef0e17c1-f83c-47f8-8ff1-8e6d67c629b1
Device Description
Catheter Placement Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| PND | Midline catheter | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32151 | Peripheral vascular intervention infusion catheter | A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741226868 | GS1 | CA | 6 | In Commercial Distribution | |
| Primary | 00801741226861 | GS1 |
Customer Contacts
- Phone
- +1(800)545-0890
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 18 | Gauge | |
| Length | 8 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius