FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Intraosseous Vascular Access System
DI: 00801741163579
·
Model: D001001
·
Bard Access Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BD Intraosseous Vascular Access System
- Primary DI
- 00801741163579
- Version / Model
- D001001
- Catalog Number
- D001001
- Company Name
- Bard Access Systems, Inc.
- Labeler DUNS
- 044611812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-25
- Public Version
- 2
- Public Version Date
- 2020-01-22
- Public Version Status
- Update
- Public Device Record Key
- 07c71822-aede-4a34-a063-89f4b9c192b7
Device Description
BD Intraosseous Powered Driver
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMI | Needle, hypodermic, single lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62075 | Intraosseous-access handpiece, infusion, electric | A hand-held, battery-powered device designed to be used with a separate rotary cutting needle (endpiece) to access bone marrow for intraosseous infusion of fluids and medication. It is used as an alternative to intravenous (IV) access typically when IV access is not feasible. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741163576 | GS1 | CA | 1 | In Commercial Distribution | |
| Primary | 00801741163579 | GS1 |
Customer Contacts
- Phone
- +1(800)545-0890
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal