Sterile Single-use Syringe with Needle

GUDID 16920756728588

Jiangxi Hongda Medical Equipment Group Ltd.

General-purpose syringe/needle

• Primary Device ID: 16920756728588
• NIH Device Record Key: 5a8be6b6-65f0-433f-b1c5-4a7771e0835f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Single-use Syringe with Needle
• Version Model Number: 60mL LL 21G×1" (0.8mm×25mm)
• Company DUNS: 526963345
• Company Name: Jiangxi Hongda Medical Equipment Group 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06920756728581 [Primary]
GS1	16920756728588 [Package]; Contains: 06920756728581; Package: [50 Units]; In Commercial Distribution
GS1	26920756728585 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163161

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: 2021-02-02
• Device Publish Date: 2021-01-25

On-Brand Devices [Sterile Single-use Syringe with Needle]

• 16920756729998: 1mL LS 30G×1/2" (0.3mm×13mm)
• 16920756729981: 1mL LS 29G×1/2" (0.33mm×13mm)
• 16920756729974: 1mL LS 28G×1/2" (0.36mm×13mm)
• 16920756729967: 1mL LS 27G×1/2" (0.4mm×13mm)
• 16920756729950: 1mL LS 26G×1/2" (0.45mm×13mm)
• 16920756729943: 1mL LS 26G×5/8" (0.45mm×16mm)
• 16920756729936: 1mL LS 25G×5/8" (0.5mm×16mm)
• 16920756729929: 1mL LS 25G×1" (0.5mm×25mm)
• 16920756729912: 1mL LS 25G×1 1/2" (0.5mm×38mm)
• 16920756729905: 1mL LS 23G×1" (0.6mm×25mm)
• 16920756729899: 1mL LS 23G×1 1/4" (0.6mm×32mm)
• 16920756729882: 1mL LS 23G×1 1/2" (0.6mm×38mm)
• 16920756729875: 1mL LL 30G×1/2" (0.3mm×13mm)
• 16920756729868: 1mL LL 29G×1/2" (0.33mm×13mm)
• 16920756729851: 1mL LL 28G×1/2" (0.36mm×13mm)
• 16920756729844: 1mL LL 27G×1/2" (0.4mm×13mm)
• 16920756729837: 1mL LL 26G×1/2" (0.45mm×13mm)
• 16920756729820: 1mL LL 26G×5/8" (0.45mm×16mm)
• 16920756729813: 1mL LL 25G×5/8" (0.5mm×16mm)
• 16920756729806: 1mL LL 25G×1" (0.5mm×25mm)
• 16920756729790: 1mL LL 25G×1 1/2" (0.5mm×38mm)
• 16920756729783: 1mL LL 23G×1" (0.6mm×25mm)
• 16920756729776: 1mL LL 23G×1 1/4" (0.6mm×32mm)
• 16920756729769: 1mL LL 23G×1 1/2" (0.6mm×38mm)
• 16920756729752: 3mL LS 25G×5/8"(0.5mm×16mm)
• 16920756729745: 3mL LS 25G×1"(0.5mm×25mm)
• 16920756729738: 3mL LS 25G×1 1/2"(0.5mm×38mm)
• 16920756729721: 3mL LS 23G×1"(0.6mm×25mm)
• 16920756729714: 3mL LS 23G×1 1/4"(0.6mm×32mm)
• 16920756729707: 3mL LS 23G×1 1/2"(0.6mm×38mm)
• 16920756729691: 3mL LS 22G×1"(0.7mm×25mm)
• 16920756729684: 3mL LS 22G×1 1/4"(0.7mm×32mm)
• 16920756729677: 3mL LS 22G×1 1/2"(0.7mm×38mm)
• 16920756729660: 3mL LS 21G×1"(0.8mm×25mm)
• 16920756729653: 3mL LS 21G×1 1/4"(0.8mm×32mm)
• 16920756729646: 3mL LS 21G×1 1/2"(0.8mm×38mm)
• 16920756729639: 3mL LS 20G×1"(0.9mm×25mm)
• 16920756729622: 3mL LS 20G×1 1/4"(0.9mm×32mm)
• 16920756729615: 3mL LS 20G×1 1/2"(0.9mm×38mm)
• 16920756729608: 3mL LL 25G×5/8"(0.5mm×16mm)
• 16920756729592: 3mL LL 25G×1"(0.5mm×25mm)
• 16920756729585: 3mL LL 25G×1 1/2"(0.5mm×38mm)
• 16920756729578: 3mL LL 23G×1"(0.6mm×25mm)
• 16920756729561: 3mL LL 23G×1 1/4"(0.6mm×32mm)
• 16920756729554: 3mL LL 23G×1 1/2"(0.6mm×38mm)
• 16920756729547: 3mL LL 22G×1"(0.7mm×25mm)
• 16920756729530: 3mL LL 22G×1 1/4"(0.7mm×32mm)
• 16920756729523: 3mL LL 22G×1 1/2"(0.7mm×38mm)
• 16920756729516: 3mL LL 21G×1"(0.8mm×25mm)
• 16920756729509: 3mL LL 21G×1 1/4"(0.8mm×32mm)