BD Hypoint™ 301390
GUDID 50382903013901
BD Hypoint Needle is a hypodermic single lumen needle designed, for use with syringes and injection devices for general purpose fluid injection /aspiration.
BECTON DICKINSON MEDICAL (S) PTE LTD
Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use| Primary Device ID | 50382903013901 |
| NIH Device Record Key | 833bcbc1-ffe2-4caa-a389-feac67176da8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD Hypoint™ |
| Version Model Number | 301390 |
| Catalog Number | 301390 |
| Company DUNS | 595883083 |
| Company Name | BECTON DICKINSON MEDICAL (S) PTE LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2 Inch |
| Needle Gauge | 20 Gauge |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382903013906 [Primary] |
| GS1 | 50382903013901 [Package] Contains: 00382903013906 Package: Case [3000 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K070440
FDA Product Code
| FMI | Needle, hypodermic, single lumen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
[50382903013901]
Radiation Sterilization
[50382903013901]
Radiation Sterilization
[50382903013901]
Radiation Sterilization
[50382903013901]
Radiation Sterilization
[50382903013901]
Radiation Sterilization
[50382903013901]
Radiation Sterilization
[50382903013901]
Radiation Sterilization
[50382903013901]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-04 |
| Device Publish Date | 2020-04-24 |
On-Brand Devices [BD Hypoint™]
| 50382903013901 | BD Hypoint Needle is a hypodermic single lumen needle designed, for use with syringes and inject |
| 50382903002646 | BD Hypoint Needle is a hypodermic single lumen needle designed, for use with syringes and inject |
| 50382903002639 | BD Hypoint Needle is a hypodermic single lumen needle designed, for use with syringes and inject |
| 50382903002554 | BD Hypoint Needle is a hypodermic single lumen needle designed, for use with syringes and inject |
| 50382903002493 | BD Hypoint Needle is a hypodermic single lumen needle designed, for use with syringes and inject |
| 50382903002080 | BD Hypoint Needle is a hypodermic single lumen needle designed, for use with syringes and inject |
| 50382903002530 | BD Hypoint Needle is a hypodermic single lumen needle designed, for use with syringes and inject |
Trademark Results [BD Hypoint]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BD HYPOINT 78866755 3413261 Live/Registered |
Becton, Dickinson and Company 2006-04-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.