K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET PA04021

GUDID 00646311553257

K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncoring Huber needle that is used to access an implanted medication port for solution infusion. The Port Access Infusion Set is designed with an integral safety device intended to protect against accidental needlestick injuries when removing the device from the implanted port.

KAWASUMI LABORATORIES, INCORPORATED

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• Primary Device ID: 00646311553257
• NIH Device Record Key: d3f05959-4dcd-44d1-9515-4c081d0fd4e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET
• Version Model Number: PA04021
• Catalog Number: PA04021
• Company DUNS: 690625850
• Company Name: KAWASUMI LABORATORIES, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com
• Phone: (813) 630-5554
• Email: info@kawasumiamerica.com

Device Dimensions

• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge
• Needle Gauge: 22 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00646311553257 [Primary]

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-08-20

On-Brand Devices [K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET]

• 00646311553073: PA04021
• 00646311553066: PA01N21
• 00646311553059: PA03021
• 00646311553042: PA04020
• 00646311553035: PA01N20
• 00646311553028: PA03020
• 00646311553011: PA04001
• 00646311553004: PA01N01
• 00646311552991: PA03001
• 00646311552984: PA04000
• 00646311552977: PA01N00
• 00646311552960: PA03000
• 00646311552953: PA04091
• 00646311552946: PA01N91
• 00646311552939: PA03091
• 00646311552922: PA04090
• 00646311552915: PA01N90
• 00646311552908: PA03090
• 00646311553257: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553240: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553233: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553226: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553219: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553202: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553196: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553189: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553172: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553165: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553158: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553141: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553134: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553127: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553110: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553103: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553097: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor
• 00646311553080: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncor