Pen Needle 320617
GUDID 50382903206174
PN RELION 31G X 6MM 3B TW 50CT
Suzhou BD Medical Device Co., Ltd
Autoinjector needle| Primary Device ID | 50382903206174 |
| NIH Device Record Key | b8b42c23-b6f6-4588-9144-a6fddaafc68f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pen Needle |
| Version Model Number | 681131386807 |
| Catalog Number | 320617 |
| Company DUNS | 420025124 |
| Company Name | Suzhou BD Medical Device Co., Ltd |
| Device Count | 50 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Device Dimensions
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681131386807 [Primary] |
| GS1 | 50382903206174 [Package] Contains: 00681131386807 Package: Case [18 Units] In Commercial Distribution |
| GS1 | 80382903206175 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162516
FDA Product Code
| FMI | Needle, hypodermic, single lumen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-18 |
| Device Publish Date | 2022-10-10 |
On-Brand Devices [Pen Needle]
| 50382903206174 | PN RELION 31G X 6MM 3B TW 50CT |
| 50382903206181 | PN 31G X 8MM 3B TW 50CT |
Trademark Results [Pen Needle]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PEN NEEDLE 87159412 not registered Dead/Abandoned |
Ko Pen Wang, MD 2016-09-02 |
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