CARDINAL HEALTH ED12905-IN

GUDID 35019517065590

SMITHS MEDICAL ASD, INC.

Insulin syringe/needle, basic Insulin syringe/needle, basic

• Primary Device ID: 35019517065590
• NIH Device Record Key: 4c096634-ee3c-44fe-80e1-b855d097ddd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARDINAL HEALTH
• Version Model Number: ED12905-IN
• Catalog Number: ED12905-IN
• Company DUNS: 137835299
• Company Name: SMITHS MEDICAL ASD, INC.
• Device Count: 1
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019517065596 [Primary]
GS1	35019517065590 [Package]; Contains: 15019517065596; Package: BOX [100 Units]; In Commercial Distribution
GS1	55019517065594 [Package]; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063755

FDA Product Code

• MEG: SYRINGE, ANTISTICK

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [CARDINAL HEALTH]

• 15019517065947: ED181-NO
• 35019517065934: ED32558-CM
• 35019517065910: ED3251-CM
• 35019517065903: ED3231-CM
• 35019517065897: ED32215-CM
• 55019517065877: ED32115-CM
• 35019517065866: ED3211-CM
• 55019517065853: ED3201-CM
• 35019517065842: ED3181-CM
• 35019517065835: ED27125-NO
• 35019517065828: ED2705-NO
• 55019517065815: ED2558-NO
• 35019517065804: ED2515-NO
• 35019517065781: ED251-NO
• 55019517065778: ED2315-NO
• 35019517065767: ED231-NO
• 35019517065750: ED2215-NO
• 35019517065743: ED221-NO
• 55019517065730: ED2115-NO
• 35019517065729: ED211-NO
• 55019517065709: ED2015-NO
• 35019517065682: ED201-NO
• 55019517065679: ED191-NO
• 35019517065668: ED1815-NO
• 35019517065620: ED12705-TB
• 55019517065617: ED12638-TB
• 55019517065600: ED12558-TB
• 35019517065590: ED12905-IN
• 55019517065587: ED12805-IN
• 35019517065576: ED053005IN
• 55019517065563: ED052905IN
• 35019517065552: ED052805IN
• 35019517065545: ED032905IN