FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Vacutainer® Luer-Lok™ Access Device
DI: 00382903649020
·
Model: 36490200
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BD Vacutainer® Luer-Lok™ Access Device
- Primary DI
- 00382903649020
- Version / Model
- 36490200
- Catalog Number
- 36490200
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-09
- Public Version
- 6
- Public Version Date
- 2026-03-09
- Public Version Status
- Update
- Public Device Record Key
- 6b859569-1828-47af-9563-8a6490e20a86
Device Description
BD LUER-LOK ACCESS DEVICE
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
- Yes
- 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 |
|---|---|---|---|---|
| JKA | Tubes, vials, systems, serum separators, blood collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60579 | Luer-ended blood collection tube spike | A device intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from blood collection tubing or a needle to a blood specimen receptacle (e.g., evacuated blood collection tube, adapted syringe). It is designed to be fitted to a blood collection tube holder, where it connects to the tubing or needle via a Luer connection at one end, and penetrates an evacuated blood collection tube at the other end for blood collection. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60382903649022 | GS1 | Case | 198 | Not in Commercial Distribution | 2026-02-27 |
| Primary | 00382903649020 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222478 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- This way up
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight