FDA UDI
In Commercial Distribution
🇺🇸 United States
BD PosiFlush
DI: 00382903064953
·
Model: 306495
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- BD PosiFlush
- Primary DI
- 00382903064953
- Version / Model
- 306495
- Catalog Number
- 306495
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-05
- Public Version
- 3
- Public Version Date
- 2025-08-07
- Public Version Status
- Update
- Public Device Record Key
- 1c40f4bf-4228-4422-84b3-5e30d2de01fc
Device Description
SYRINGE 10ML SHORT PR SALINE 5ML FILL
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 |
|---|---|---|---|---|
| NGT | Saline, vascular access flush | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64786 | Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial | A solution (e.g., saline, sterile water) intended to flush the lumen of an in situ intravenous access device (IVAD), typically a peripheral intravenous cannula or central venous catheter, to maintain patency; it does not include an anticoagulant or antimicrobial agent. Also known as lock solution, the device is available in a small container (e.g., bottle) or prefilled syringe. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382903064953 | GS1 | ||||
| Package | 50382903064958 | GS1 | Case | 16 | In Commercial Distribution | |
| Package | 30382903064954 | GS1 | Pack or Inner Pack | 30 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161552 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size = Fill Volume = 5 millilitre (mL) |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze