Getinge Pack Self-Seal Pouch 61301606728

GUDID 10850144008052

Self-Seal Pouch 25cm x 38cm

PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI

Sterilization packaging, single-use

• Primary Device ID: 10850144008052
• NIH Device Record Key: 710dc396-0993-47d1-9f82-2987c1f7dadf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Getinge Pack Self-Seal Pouch
• Version Model Number: GUKP2538
• Catalog Number: 61301606728
• Company DUNS: 565751992
• Company Name: PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
• Device Count: 200
• 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: 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: true

Customer Support Contacts

• Phone: 4196935300
• Email: rdean@lexamed.net

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850144008055 [Primary]
GS1	10850144008052 [Package]; Contains: 00850144008055; Package: Case [3 Units]; In Commercial Distribution
GS1	20850144008059 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152669

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-09-10

On-Brand Devices [Getinge Pack Self-Seal Pouch]

• 00850144008079: Self-Seal Pouch 33cm x 46cm
• 00850144008062: Self-Seal Pouch 30cm x 45cm
• 10850144008052: Self-Seal Pouch 25cm x 38cm
• 00850144008048: Self-Seal Pouch 20cm x 41cm
• 10850144008038: Self-Seal Pouch 15cm x 30cm
• 10850144008021: Self-Seal Pouch 13cm x 38cm
• 10850144008014: Self-Seal Pouch 10cm x 28cm
• 10850144008007: Self-Seal Pouch 9cm x 25cm