Elite Medtek

GUDID 06939147402030

Elite Medtek (Jiangsu) Co., Ltd.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 06939147402030
• NIH Device Record Key: b530e57c-ac6f-4dad-912f-7d86e0a4a27c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite Medtek
• Version Model Number: EM-ID-M30S
• Company DUNS: 542974341
• Company Name: Elite Medtek (Jiangsu) Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06939147402030 [Primary]

FDA Product Code

• PTM: Syringe, Balloon Inflation, Exempt

Sterilization

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

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

[06939147402030]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-20
• Device Publish Date: 2020-08-12

On-Brand Devices [Elite Medtek]

• 06939147402030: EM-ID-M30S
• 06939147402276: EM-ID-M14S