Medex

GUDID 50351688510738

SMITHS MEDICAL ASD, INC.

General/plastic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 50351688510738
• NIH Device Record Key: cac8bad5-7b3a-4a4b-a681-8303d2950466
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medex
• Version Model Number: M20553
• Company DUNS: 828611934
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10351688510730 [Primary]
GS1	50351688510738 [Package]; Contains: 10351688510730; Package: CASE [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K820355

FDA Product Code

• DRS: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Sterilization

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

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

[50351688510738]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-11-06
• Device Publish Date: 2016-10-11

On-Brand Devices [Medex]

• 50351688518352: MX964Z37
• 50351688518345: MX963Z37
• 50351688518338: MX964Z29
• 50351688518321: MX962Z29
• 50351688504560: MX90006
• 50351688504553: MX90008
• 50351688504546: MX90012
• 50351688504539: MX90013
• 50351688504515: MX90015
• 50351688504508: MX90017
• 50351688504492: MX90020
• 50351688504485: MX90028
• 50351688504478: MX90034
• 50351688504461: MX90042
• 50351688504454: MX90044
• 50351688504416: MX90108
• 50351688504409: MX90118
• 50351688504393: MX90119
• 50351688504362: MX90125
• 50351688504348: MX90137
• 50351688504331: MX90147
• 50351688504324: MX90157
• 50351688504317: MX90158
• 50351688504300: MX90163
• 50351688504294: MX90164
• 50351688504287: MX90167
• 50351688504270: MX90167
• 50351688504263: MX90173
• 50351688504256: MX90174
• 50351688504249: MX90175
• 50351688504133: MX94050
• 50351688504119: MX95028
• 50351688504102: MX95009
• 50351688504096: MX95012
• 50351688504089: MX95017
• 50351688504065: MX95020
• 50351688504027: MX95053
• 50351688504010: MX95056L39
• 50351688504003: MX95056L79
• 50351688503976: MX95080
• 50351688503907: MX95101
• 50351688503891: MX95102
• 50351688503884: MX95103
• 50351688503877: MX95104
• 50351688503860: MX95105
• 50351688503853: MX95108
• 50351688503839: MX95113
• 50351688503822: MX95114
• 50351688503815: MX95115
• 50351688503808: MX95119