Insyte Autoguard
- Primary DI
- 50382903829472
- Brand
- Insyte Autoguard
- Company
- BECTON, DICKINSON AND COMPANY
- Model
- 382947
- Catalog number
- 382947
- Device description
- BD Insyte™ Autoguard™ BC Pro Winged Shielded IV Catheter Blood Control Technology 18 GA x 1.88 IN
- Published
- 2026-02-13
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| DYB | Introducer, catheter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K251654 | 000 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K251654 | 000 | BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-06-27 | FOZ |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 30382903829478 | Package | GS1 | 50 | In Commercial Distribution |
| 50382903829472 | Package | GS1 | 4 | In Commercial Distribution |
| 00382903829477 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 30382903829478 | 30382903829478 | ||
| 50382903829472 | 50382903829472 | ||
| 00382903829477 | 00382903829477 | 382903829477 | 0382903829477 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Length | 48 | Millimeter |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Fragile, handle with care |
| Special Storage Condition, Specify | 0 | 0 | Keep away from sunlight |
| Special Storage Condition, Specify | 0 | 0 | Keep dry |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 124987988
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00885403523475 | HemoSphere Alta | ALTACR1 | ALTACR1 | 2026-08-06 |
| 00382906718167 | Horizon | 671816 | 671816 | 2026-09-24 |
| 00382906718174 | Horizon | 671817 | 671817 | 2026-09-24 |
| 00382906718181 | Horizon | 671818 | 671818 | 2026-09-24 |
| 00382906718198 | Horizon | 671819 | 671819 | 2026-09-24 |
| 00382906718204 | Horizon | 671820 | 671820 | 2026-09-24 |
| 00382906718211 | Horizon | 671821 | 671821 | 2026-09-24 |
| 00382906718235 | Horizon | 671823 | 671823 | 2026-09-24 |
| 00382906718242 | Horizon | 671824 | 671824 | 2026-09-24 |
| 00382906718259 | Horizon | 671825 | 671825 | 2026-09-24 |
| 00382906718266 | Horizon | 671826 | 671826 | 2026-09-24 |
| 00382906718273 | Horizon | 671827 | 671827 | 2026-09-24 |
| 00382906718280 | Horizon | 671828 | 671828 | 2026-09-24 |
| 00382906718310 | Horizon | 671831 | 671831 | 2026-09-24 |
| 00382906718327 | Horizon | 671832 | 671832 | 2026-09-24 |
| 00382906718334 | Horizon | 671833 | 671833 | 2026-09-24 |
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