FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Saf-T-Intima
DI: 00382903833238
·
Model: 383323
·
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 Saf-T-Intima
- Primary DI
- 00382903833238
- Version / Model
- 383323
- Catalog Number
- 383323
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 124987988
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-20
- Public Version
- 4
- Public Version Date
- 2026-01-07
- Public Version Status
- Update
- Public Device Record Key
- 00af9e77-35a8-4a69-8cc9-0ec0045024c8
Device Description
BD Saf-T-Intima™ Subcutaneous Catheter System Dual Port 22 GA x 0.75 in
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 |
|---|---|---|---|---|
| FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64575 | Peripheral artery cannula | A short, thin tube intended for short-term (<= 30 days) percutaneous access to a peripheral artery for invasive blood pressure monitoring and arterial blood sampling; it may in addition be intended for peripheral intravenous (IV) or subcutaneous use for blood sampling or administration of fluid/medication. Also referred to as a peripheral arterial catheter, it is used with an external blood pressure transducer (not included) to enable pressure measurements; it does not include electronic sensors and is not intended for advancement into the vasculature. It may include devices dedicated to introduction/function (e.g., introducer needle, guidewire, adaptor). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50382903833233 | GS1 | Case | 8 | In Commercial Distribution | |
| Primary | 00382903833238 | GS1 | ||||
| Package | 30382903833239 | GS1 | Shelfpack | 25 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 0.75 | Inch | |
| Device Size Text, specify | Size = Catheter Gauge = 22 Gauge (G) |