ChemoPlus CT21921

GUDID 10884521040564

Neoprene Hand Specific Gloves,Medium, 9 mil

Cardinal Health, Inc.

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 10884521040564
• NIH Device Record Key: 1c9e6509-1eef-461a-b511-da512a3989ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ChemoPlus
• Version Model Number: CT21921
• Catalog Number: CT21921
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521040564 [Package]; Contains: 20884521040561; Package: CASE [300 Units]; In Commercial Distribution
GS1	20884521040561 [Primary]
GS1	30884521040568 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002064

FDA Product Code

• LZA: Polymer patient examination glove

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-17
• Device Publish Date: 2018-06-27

On-Brand Devices [ChemoPlus]

• 20884527004482: Chemo Preparation and Administration Kit
• 10884527005673: Red IVA Seals
• 10884527005666: Green IVA Seals
• 10884527005284: Yellow IVA Seals
• 10884527005277: Tan IVA Seals
• 10884527005260: Orange IVA Seals
• 10884527005253: Blue IVA Seals
• 10884527005246: Silver IVA Seals
• 10884527004386: Prep Mat
• 10884527004379: Prep Mat
• 10884527004362: Prep Mat
• 00884527004228: Vial Vent Chemo Dispensing Pin
• 10884521041356: Nitrile Ambidextrous Gloves,Large, 8 mil
• 10884521040564: Neoprene Hand Specific Gloves,Medium, 9 mil
• 20884527021120: Nitrile Ambidextrous Gloves,X-Large, 8 mil
• 20884527004529: Chemo Preparation and Administration Kit
• 20884527004512: Chemo Preparation and Administration Kit
• 20884527004505: Chemo Preparation and Administration Kit
• 20884527004499: Chemo Preparation and Administration Kit
• 20884527004475: Chemo Preparation and Administration Kit
• 20884527004468: Chemo Preparation and Administration Kit
• 20884527004451: Chemo Spill Kit
• 30884527004441: Chemo Spill Kit
• 20884527004437: Chemo Spill Kit
• 20884521746067: Chemo Spill Kit
• 20884521040905: Nitrile Ambidextrous Gloves,Medium, 8 mil
• 20884521040868: Nitrile Ambidextrous Gloves,Small, 8 mil
• 20884521040776: Latex Hand Specific Gloves,Large, 10 mil
• 20884521040653: Latex Hand Specific Gloves,Medium, 10 mil
• 20884521040622: Latex Hand Specific Gloves,Small, 10 mil
• 20884521040608: Neoprene Hand Specific Gloves,X-Large, 9 mil
• 20884521040592: Neoprene Hand Specific Gloves,Large, 9 mil
• 20884521040547: Neoprene Hand Specific Gloves,Small, 9 mil
• 20884521040530: Latex Hand Specific Gloves,X-Large, 18 mil
• 20884521040080: Latex Hand Specific Gloves,Small, 18 mil
• 20884527006400: IVA Seals
• 20884527006394: IVA Seals
• 20884527006387: IVA Seals
• 20884527006370: IVA Seals
• 20884527006363: Red IVA Seals
• 20884527006356: Blue IVA Seals
• 20884527006349: Yellow IVA Seals
• 20884527006332: Red IVA Seals
• 20884527006325: Blue IVA Seals
• 20884527006318: Silver IVA Seals
• 20884527006301: Red IVA Seals
• 10884527006298: Orange IVA Seals
• 10884527006281: Green IVA Seals
• 20884527006271: Blue IVA Seals
• 20884527006264: Silver IVA Seals