Ethox

GUDID 10816317023000

Ethox Pressure Infusor Bag with Hook 500cc

RENU MEDICAL, INC

Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use Intravenous pressure infusor, manual, single-use

• Primary Device ID: 10816317023000
• NIH Device Record Key: 31832f65-7c20-4c30-a090-255607ed9aac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ethox
• Version Model Number: RM-4005H
• Company DUNS: 100439103
• Company Name: RENU MEDICAL, INC
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816317023003 [Primary]
GS1	10816317023000 [Package]; Contains: 00816317023003; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• KZD: Infusor, Pressure, For I.V. Bags

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-05
• Device Publish Date: 2023-06-27

On-Brand Devices [Ethox]

• 10816317023017: Ethox Pressure Infusor Bag with Hook 1000cc
• 10816317023000: Ethox Pressure Infusor Bag with Hook 500cc