EXEL 1/2mL INS 28GX1/2" 26032

GUDID 10020221260325

EXEL 1/2mL INS 28GX1/2" BULK PAK; STERILE; 10/POLY BAG, 4500/CRTN

Exel International

Insulin syringe/needle, basic

• Primary Device ID: 10020221260325
• NIH Device Record Key: 623e23b3-9658-4d84-871b-a6ef8d57db6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL 1/2mL INS 28GX1/2"
• Version Model Number: 26032
• Catalog Number: 26032
• Company DUNS: 180572216
• Company Name: Exel International
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221260328 [Primary]
GS1	10020221260325 [Package]; Contains: 00020221260328; Package: Bag [10 Units]; In Commercial Distribution
GS1	20020221260322 [Package]; Contains: 00020221260328; Package: Shipping carton [450 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861153

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: 2023-03-23
• Device Publish Date: 2023-03-15

Devices Manufactured by Exel International

• 10020221260233 - EXEL 1/2mL INS SYR 28GX1/2": 2024-12-03 EXEL 1/2mL INS SYR 28GX1/2", 100/BX, 500/CS, 6CS/CRTN
• 20020221260032 - EXEL Comfort Point Insulin Pen Needles: 2024-06-26 Insulin Pen Needle, 29G x 1/2
• 20020221260049 - EXEL Comfort Point Insulin Pen Needles: 2024-06-26 Insulin Pen Needle, 31G x 1/4
• 20020221260056 - EXEL Comfort Point Insulin Pen Needles: 2024-06-26 Insulin Pen Needle, 31G x 1/3
• 20020221260063 - EXEL Comfort Point Insulin Pen Needles: 2024-06-26 Insulin Pen Needle, 31G x 1/6
• 10020221277644 - Exel SecureTouch Safety Blood Collection Set: 2024-03-19 Safety Scalp Vein Set/Multi-Sample Luer Adapter, 21G X 3/4, 12" tube
• 00020221277661 - Exel SecureTouch Safety Blood Collection Set: 2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 23G X 3/4, 12" tube
• 00020221277685 - Exel SecureTouch Safety Blood Collection Set: 2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 25G X 3/4, 12" tube