CarePoint Precision

GUDID 00786227230078

30G x 1/2" Poly Hub Needle

ALLISON MEDICAL, INC.

Hypodermic needle, single-use

• Primary Device ID: 00786227230078
• NIH Device Record Key: b902771e-3f44-436f-84aa-3a5a6f94ac60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarePoint Precision
• Version Model Number: 202-3005
• Company DUNS: 825097264
• Company Name: ALLISON MEDICAL, INC.
• Device Count: 100
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch
• Needle Gauge: 30 Gauge
• Length: 0.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00786227230016 [Unit of Use]
GS1	00786227230054 [Primary]
GS1	00786227230078 [Package]; Contains: 00786227230054; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K124037

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: 2023-12-07
• Device Publish Date: 2023-11-29

On-Brand Devices [CarePoint Precision]

• 00786227230078: 30G x 1/2" Poly Hub Needle
• 00786227227078: 27G x 1/2" Poly Hub Needle
• 00786227225579: 25G x 5/8" Poly Hub Needle
• 00786227225173: 25G x 1-1/2" Poly Hub Needle
• 00786227225074: 25G x 1" Poly Hub Needle
• 00786227223179: 23G x 1-1/2" Poly Hub Needle
• 00786227223070: 23G x 1" Poly Hub Needle
• 00786227222172: 22G x 1-1/2" Poly Hub Needle
• 00786227222011: 22G x 1" Poly Hub Needle
• 00786227221571: 1ml Luer Slip TB with 25G x 5/8" Needle
• 00786227221175: 21G x 1-1/2" Poly Hub Needle
• 00786227221076: 21G x 1" Poly Hub Needle
• 00786227220079: 20G x 1" Poly Hub Needle
• 00786227218175: 18G x 1-1/2" Poly Hub Needle
• 00786227218076: 18G x 1" Poly Hub Needle
• 00786227053974: 3ml Luer Lock Syringe w/ 25G x 1"
• 00786227053875: 3ml Luer Lock Syringe w/ 23g x 1.5”
• 00786227053776: 3ml Luer Lock Syringe w/ 23G x 1"
• 00786227053677: 3ml Luer Lock Syringe w/ 22G x 1.5"
• 00786227053578: 3ml Luer Lock Syringe w/ 22G x 1"
• 00786227053370: 3mL Luer Lock Syringe w/ 21G x 1"
• 00786227053271: 3ml Luer Lock Syringe w/ 20G x 1.5"
• 00786227053172: 3ml Luer Lock Syringe w/ 20G x 1"
• 00786227053073: 3ml Luer Lock Syringe w/ 25G x 1.5"
• 00786227046570: 60mL Catheter Tip Syringe
• 00786227046075: 60mL Luer Lock Syringe
• 00786227043074: 30mL Luer Lock Syringe
• 00786227042077: 20mL Luer Lock Syringe
• 00786227041070: 10mL Luer Lock Syringe
• 00786227040578: 5mL Luer Lock Syringe
• 00786227040370: 3mL Luer Lock Syringe
• 00786227040172: 1mL Luer Lock Syringe
• 00786227016078: 60mL Luer Slip Syringe
• 00786227010175: 1mL Luer Slip Syringe