FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Prevue II Peripheral Vascular Access System
DI: 00801741222566
·
Model: 9770705
·
Bard Access Systems, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BD Prevue II Peripheral Vascular Access System
- Primary DI
- 00801741222566
- Version / Model
- 9770705
- Catalog Number
- 9770705
- Company Name
- Bard Access Systems, Inc.
- Labeler DUNS
- 044611812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-17
- Public Version
- 2
- Public Version Date
- 2024-01-09
- Public Version Status
- Update
- Public Device Record Key
- d055fa4f-43ea-4f8d-b03c-8dd2c880ebd0
Device Description
BD Prevue II Magnetizer Cover
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
- No
- 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 |
|---|---|---|---|---|
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
| IYO | System, imaging, pulsed echo, ultrasonic | Radiology | 892.1560 | 2 |
| LLZ | System, image processing, radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63247 | Surgical instrument guard, single-use | A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741222563 | GS1 | CA | 25 | In Commercial Distribution | |
| Primary | 00801741222566 | GS1 |
Customer Contacts
- Phone
- +1(800)545-0890
- [email protected]