FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Syringe NRFit™ Lok
DI: 00382904001834
·
Model: 400183
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BD Syringe NRFit™ Lok
- Primary DI
- 00382904001834
- Version / Model
- 400183
- Catalog Number
- 400183
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-21
- Public Version
- 2
- Public Version Date
- 2023-12-25
- Public Version Status
- Update
- Public Device Record Key
- 9e29573e-ed9a-4e42-b68b-e52dab30facf
Device Description
BD® 50mL Syringe NRFit™ Lok
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
- 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 |
|---|---|---|---|---|
| QEH | Piston Syringe with neuraxial connector – epidural, peripheral, and/or indirect cerebral spinal fluid contact | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63603 | Neuraxial syringe | A sterile device consisting of a calibrated barrel (cylinder) with plunger intended for neuraxial applications (to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes). At the distal end of the barrel is a male connector, designed according to ISO 80369-6 (often referred to as an NRFit connection), intended specifically for connection to neuraxial devices (e.g., needles, catheters, tubing) with the appropriate NRFit connection. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50382904001839 | GS1 | Case | 4 | In Commercial Distribution | |
| Primary | 00382904001834 | GS1 | ||||
| Package | 30382904001835 | GS1 | Shelfpack | 40 | In Commercial Distribution |