EXEL HIS ROTATING WING, NON-DEHP W/O Y 20GX1" 27954R

GUDID 10020221079545

EXEL HIS ROTATING WING, NON-DEHP W/O Y 20GX1", 25/INNERBX, 50/BX, 20BX/CRTN

Exel International

Subcutaneous infusion/injection port needle

• Primary Device ID: 10020221079545
• NIH Device Record Key: d1ea7ca2-444e-4db7-a808-3dc7d363a7ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL HIS ROTATING WING, NON-DEHP W/O Y 20GX1"
• Version Model Number: 27954R
• Catalog Number: 27954R
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221079548 [Primary]
GS1	10020221079545 [Package]; Contains: 00020221079548; Package: Inner box [25 Units]; In Commercial Distribution
GS1	20020221079542 [Package]; Package: Case [2 Units]; In Commercial Distribution
GS1	30020221079549 [Package]; Contains: 20020221079542; Package: Shipping carton [20 Units]; In Commercial Distribution

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2023-04-17
• Device Publish Date: 2023-04-07

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• 20020221260056 - EXEL Comfort Point Insulin Pen Needles: 2024-06-26 Insulin Pen Needle, 31G x 1/3
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• 00020221277685 - Exel SecureTouch Safety Blood Collection Set: 2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 25G X 3/4, 12" tube