Envirosystems PB013

GUDID 50724995010336

The Envirosystems Ethylene Oxide (EO) Sterilant gas cartridge is a single-unit dose for the Amsco Eagle 3017 EO Sterilizer.

STERIS CORPORATION

Ethylene oxide device sterilant

• Primary Device ID: 50724995010336
• NIH Device Record Key: 26c80342-b718-4555-a3d8-60ec65ef5952
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Envirosystems
• Version Model Number: PB013
• Catalog Number: PB013
• Company DUNS: 139424188
• Company Name: STERIS CORPORATION
• Device Count: 12
• 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: false
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Dimensions

• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not contaminate water, food, or feed by storage or disposal
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not contaminate water, food, or feed by storage or disposal
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Do not contaminate water, food, or feed by storage or disposal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995010331 [Unit of Use]
GS1	50724995010336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931872

FDA Product Code

• FLF: Sterilizer, ethylene-oxide gas

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-28
• Device Publish Date: 2016-09-08

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