CARDINAL HEALTH

GUDID 55019517065877

SMITHS MEDICAL ASD, INC.

Hypodermic needle, single-use

• Primary Device ID: 55019517065877
• NIH Device Record Key: 80b32243-9d8b-4d74-b82b-2e4092412465
• Commercial Distribution Discontinuation: 2018-04-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CARDINAL HEALTH
• Version Model Number: ED32115-CM
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019517065879 [Primary]
GS1	35019517065873 [Package]; Contains: 15019517065879; Package: BOX [50 Units]; Discontinued: 2018-04-30; Not in Commercial Distribution
GS1	55019517065877 [Package]; Contains: 35019517065873; Package: CASE [8 Units]; Discontinued: 2018-04-30; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061194

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: 6
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-01-19

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