FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Vacutainer® UltraTouch™ Push Button
DI: 50382903686860
·
Model: 368686
·
BECTON, DICKINSON AND COMPANY
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- BD Vacutainer® UltraTouch™ Push Button
- Primary DI
- 50382903686860
- Version / Model
- 368686
- Catalog Number
- 368686
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-09-11
- Public Version
- 1
- Public Version Date
- 2023-09-19
- Public Version Status
- New
- Public Device Record Key
- b4514faa-10c4-4a48-80f0-bfa4aa99f40c
Device Description
UT-PBBCS 21G 7 PAH CE
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
| JKA | Tubes, vials, systems, serum separators, blood collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58497 | Blood collection set, invasive | A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30382903686866 | GS1 | Shelfpack | 20 | In Commercial Distribution | |
| Primary | 50382903686860 | GS1 | ||||
| Unit of Use | 00382903686865 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212724 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature