Precision 9500SA

GUDID 10884527006823

Catheter Urine Specimen System Kit

Cardinal Health, Inc.

Midstream urine specimen container IVD

• Primary Device ID: 10884527006823
• NIH Device Record Key: f3b18358-d1df-4d3c-8816-a6a5ce6e4f84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision
• Version Model Number: 9500SA
• Catalog Number: 9500SA
• Company DUNS: 080935429
• Company Name: Cardinal Health, Inc.
• 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: 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: true

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884527006823 [Package]; Contains: 30884527006827; Package: CASE [100 Units]; In Commercial Distribution
GS1	20884527006820 [Package]; Contains: 30884527006827; Package: PACK_OR_INNER_PACK [25 Units]; In Commercial Distribution
GS1	30884527006827 [Primary]

FDA Product Code

• FMH: Container, Specimen, Sterile
• LIO: Device, specimen collection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-15
• Device Publish Date: 2018-06-30

On-Brand Devices [Precision]

• 10884527006823: Catheter Urine Specimen System Kit
• 20884527006813: Stool Collector
• 10884527006083: Specimen Container,Positive Seal Indicator, OR Packaged
• 10884527006052: Specimen Container,Plastic Screw Top Cap, OR Packaged
• 10884527006007: Specimen Container,Plastic Screw Top Cap
• 10884527005987: Specimen Container,Metal Screw Top Cap, ID Label
• 30884527004939: Specimen Container,Positive Seal Indicator
• 40884527005957: Urine Specimen System with Preservative
• 20884527006103: Midstream Preservative Kit
• 20884527004895: Tissue Grinder
• 20884527004888: Tissue Grinder
• 20884527006448: Sputum Collector Kit with Tube
• 10884527004928: Specimen Container,Positive Seal Indicator
• 20884527006806: Specimen Container,Positive Seal Indicator
• 10884527004607: Specimen Container,Positive Seal Indicator
• 10884527004584: Specimen Container,No Cap