EXEL U-40 1/2mL INS SYR 29GX1/2" 26036

GUDID 10020221260363

EXEL U-40 1/2mL INS SYR 29GX1/2", 10/BAG, 100/BX, 500/CS, 6CS/CRTN

Exel International

Insulin syringe/needle, basic

• Primary Device ID: 10020221260363
• NIH Device Record Key: 55c3ba10-58a8-43e6-8ce0-0910ae9b1d05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL U-40 1/2mL INS SYR 29GX1/2"
• Version Model Number: 26036
• Catalog Number: 26036
• 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	00020221260366 [Primary]
GS1	10020221260363 [Package]; Contains: 00020221260366; Package: Bag [10 Units]; In Commercial Distribution
GS1	20020221260360 [Package]; Package: Inner box [10 Units]; In Commercial Distribution
GS1	30020221260367 [Package]; Contains: 20020221260360; Package: Outer box [5 Units]; In Commercial Distribution
GS1	40020221260364 [Package]; Contains: 30020221260367; Package: Shipping carton [6 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

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• 00020221063004 - EXEL 50-60mL SYR ONLY L-L BULK NON STERILE; NO PRINT ON THE BARREL, NO PLUNGER S: 2025-10-07 EXEL 50-60mL SYR ONLY L-L BULK NON STERILE; NO PRINT ON THE BARREL, NO PLUNGER STOP, DOUBLE BAGGED, 100/BX, 400/CRTN.
• 00020221162011 - 3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL;: 2025-10-07 3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL; 2,000PC/DOUBLE PE BAG/CRTN
• 00020221163001 - EXEL 50-60mL SYR BARREL L-L BULK NON STERILE; NO PRINT ON THE BARREL: 2025-10-07 EXEL 50-60mL SYR BARREL L-L BULK NON STERILE; NO PRINT ON THE BARREL ; 140/BOX, 560/CRTN
• 00020221464146 - EXEL HYPO NDL 21GX1"; BULK, NON-STERILE, NON-SILICONIZED: 2025-10-07 EXEL HYPO NDL 21GX1"; BULK, NON-STERILE, NON-SILICONIZED; 20,000PCS / CASE (2X10k DOUBLE BAGS)
• 00020221660487 - EXEL 1mL TB SYR ONLY,BULK,N-S: 2025-10-07 EXEL 1mL TB SYR ONLY,BULK,N-S 2000/BAG, 4,000/CS
• 00020221660494 - EXEL 1mL SYR ONLY LUER LOCK, LDS GASKET, BULK, NON-STERILE: 2025-10-07 EXEL 1mL SYR ONLY LUER LOCK, LDS GASKET, BULK, NON-STERILE 2000/BAG, 4000/CS