FDA UDI
In Commercial Distribution
🇺🇸 United States
BD IV Start Pak
DI: 30382903861607
·
Model: 386160
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- BD IV Start Pak
- Primary DI
- 30382903861607
- Version / Model
- 386160
- Catalog Number
- 386160
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 124987988
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-10-20
- Public Version
- 3
- Public Version Date
- 2019-12-11
- Public Version Status
- Update
- Public Device Record Key
- 2dba7905-1e94-4a70-ab2f-d42f0a86ae7e
Device Description
IV START PAK W/PVP, BIOCLUSIVE
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LRS | I.V. start kit | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33963 | Peripheral intravenous catheterization support kit | A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50382903861601 | GS1 | Case | 8 | In Commercial Distribution | |
| Primary | 30382903861607 | GS1 | ||||
| Unit of Use | 00382903861606 | GS1 |