Selfinject AP03-21-00

GUDID 08586015049682

1ml U100 insulin syringe with integrated needle 30G x 1/2” (0,3 x 12,7mm) in blister packaging, for single use.

CHIRANA T.Injecta, a. s.

Insulin syringe/needle, basic

• Primary Device ID: 08586015049682
• NIH Device Record Key: d9fe1121-c449-4f6d-83f3-3fec3e9e5304
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Selfinject
• Version Model Number: U100 1ml 30G x 1/2”
• Catalog Number: AP03-21-00
• Company DUNS: 495329266
• Company Name: CHIRANA T.Injecta, a. s.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 1 Milliliter
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 30 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08586015049675 [Primary]
GS1	08586015049682 [Package]; Contains: 08586015049675; Package: box [100 Units]; In Commercial Distribution
GS1	48586015049680 [Package]; Contains: 08586015049675; Package: carton [2000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242434

FDA Product Code

• FMF: Syringe, Piston

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: 2025-06-12
• Device Publish Date: 2025-06-04

On-Brand Devices [Selfinject]

• 08586015049682: 1ml U100 insulin syringe with integrated needle 30G x 1/2” (0,3 x 12,7mm) in blister packaging
• 08586015049668: 1ml U100 insulin syringe with integrated needle 29G x 1/2” (0,33 x 12,7mm) in blister packagin