FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Insyte Autoguard
DI: 30382903814542
·
Model: 381454
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- BD Insyte Autoguard
- Primary DI
- 30382903814542
- Version / Model
- 381454
- Catalog Number
- 381454
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 124987988
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2023-11-21
- Public Version Status
- Update
- Public Device Record Key
- d4ac85da-1ddf-4ec8-8317-6989b6d38855
Device Description
INSYTE AUTOGUARD GRAY 16GA X 1.16IN
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 Conditional
- 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 |
|---|---|---|---|---|
| 64574 | Peripheral intravenous cannula | A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50382903814546 | GS1 | Case | 4 | In Commercial Distribution | |
| Primary | 30382903814542 | GS1 | ||||
| Unit of Use | 00382903814541 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201075 | 000 |