7070005

GUDID 10884521150485

Needle ATNAA

Cardinal Health, Inc.

Hypodermic needle, single-use Hypodermic needle, single-use

• Primary Device ID: 10884521150485
• NIH Device Record Key: 5d489df3-c6aa-432f-81eb-54fafd38361d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 7070005
• Catalog Number: 7070005
• Company DUNS: 080935429
• Company Name: Cardinal Health, Inc.
• Device Count: 1000
• 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: true
• OTC Over-The-Counter: false

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

• Length: 1.34 Inch
• Length: 1.34 Inch
• Length: 1.34 Inch
• Length: 1.34 Inch

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	10884521150485 [Package]; Contains: 20884521150482; Package: CASE [4000 Units]; In Commercial Distribution
GS1	20884521150482 [Primary]
GS1	30884521150489 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012736

FDA Product Code

• FMI: Needle, hypodermic, single lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 9
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-24

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• 20884521740720 - Salem Sump: 2024-03-19 SILICONE SALEM SUMP WITH ENFIT 16FR 48IN
• 20884521740737 - Salem Sump: 2024-03-19 SILICONE SALEM SUMP WITH ENFIT 18FR 48IN
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