Kendall MI00325

GUDID 90884521148136

3000 Isolation Chamber,Rectal

Cardinal Health, Inc.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 90884521148136
• NIH Device Record Key: 8d6a284a-8ecb-4b44-aeea-5e52e1b02086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kendall
• Version Model Number: MI00325
• Catalog Number: MI00325
• Company DUNS: 080935429
• Company Name: Cardinal Health, Inc.
• Device Count: 100
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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 *
• 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	90884521148136 [Primary]
GS1	90884521535950 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915333

FDA Product Code

• GXY: ELECTRODE, CUTANEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-02-15
• Device Publish Date: 2016-09-24

On-Brand Devices [Kendall]

• 00884521152765: Antimicrobial Bandage Roll
• 00884521152185: Antimicrobial Gauze Sponges
• 20884521168678: Fluff Underpad,X-Large,Moderate
• 00884521167066: Foam Border Gentle Adhesion,6 Inch x 6 Inch (15.2 cm x 15.2 cm) Pad
• 00884521167004: Foam Border Gentle Adhesion,4 Inch x 4 Inch (10.2 cm x 10.2 cm) Pad
• 00884521166953: Foam Border Gentle Adhesion,2 Inch x 4 Inch (5.1 cm x 10.2 cm) Pad
• 00884521166908: Foam Border Gentle Adhesion,2 Inch x 2 Inch (5.1 cm x 5.1 cm) Pad
• 00884521166830: Foam Border Gentle Adhesion,1 Inch x 1-3/4 Inch (2.5 cm x 4.4 cm) Pad
• 00884521157159: Stretch Bandage
• 00884521157128: Stretch Bandage
• 00884521157104: Stretch Bandage
• 00884521152154: Bandage Roll
• 00884521170783: Bandage Roll
• 00884521153069: Antimicrobial Non-adherent Pad
• 00884521170790: Antimicrobial Non-adherent Pad
• 00884521152833: Antimicrobial Adhesive Bandage
• 00884521152741: Antimicrobial Non-adherent Island Dressing
• 00884521195939: Alcohol Prep
• 00884521065904: AMD Antimicrobial Fenestrated Foam Dressing with Top Sheet,0.5% Polyhexamethylene Biguanide HCI
• 00884521020880: Hydrophilic Foam Plus Dressing,Fenestrated
• 90884521148136: 3000 Isolation Chamber,Rectal
• 90884521148112: 3100C Apnea Products
• 10884527004737: 7305 Foam Electrodes,Conductive Adhesive Hydrogel
• 20884521057941: Hydrogel Wound Dressing,Disc
• 20884521024097: Alginate Hydrocolloid Dressing,Border
• 30884521021918: Hydrogel Impregnated Gauze,USP Type VII Gauze Pad 0.25 oz (7 mL) Gel
• 50884521020960: Hydrophilic Foam Island Dressing,4 inch x 4 inch (10.2 cm x 10.2 cm) Pad
• 20884521007540: Transparent Film Dressing,Moisture Vapor Permeable
• 20884527021793: DL Disposable Cable and Lead Wire System,5 Lead Dual Connect, Adapter Required
• 20884527021786: DL Disposable Cable and Lead Wire System
• 20884527021779: DL Disposable Cable and Lead Wire System
• 10884527021765: DL Disposable Cable and Lead System
• 10884527021758: DL Disposable Lead System
• 10884527021741: DL Disposable Lead System
• 20884527021731: DL Disposable Lead System
• 10884527021727: DL Disposable Direct Connect
• 20884527021717: DL Disposable Direct Connect
• 20884527021700: DL Disposable Chest Leads
• 10884527021697: DL Disposable Cable and Lead Wire System,10 Lead, Adapter Required
• 20884527021687: DL Disposable Cable and Lead Wire System,5 Lead, Adapter Required
• 10884527021673: DL Disposable Cable and Lead Wire System,3 Lead, Adapter Required
• 20884527017284: Ultrasound Gel Bottle
• 30884527015607: 20661 Adult Multi-Function Defibrillation Electrodes,Radiotransparent
• 10884527007875: Wet Gel Electrodes,GC-11 Foam
• 10884527007851: 4603 Cloth Wet Gel Electrodes
• 20884527005878: 530 Foam Electrodes,Conductive Adhesive Hydrogel
• 20884527004901: Intrauterine Pressure Catheter,Transducer Tipped, Dual Lumen
• 10884527004874: SF450 Foam Electrodes,Conductive Adhesive Hydrogel
• 10884527004843: AC303 Cloth Electrodes,Repositionable, Conductive Adhesive Hydrogel
• 20884527004833: H69P Cloth Electrodes,Repositionable, Conductive Adhesive Hydrogel