Aira

GUDID 00810194404085

3.25" x 11" - Paper/Blue Film Self-Sealing Sterilization Pouch

AIRA, LLC

Sterilization packaging, single-use

• Primary Device ID: 00810194404085
• NIH Device Record Key: fb317af2-6dfe-4ae4-9ecd-cabc4bde85c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aira
• Version Model Number: 100546
• Company DUNS: 137437162
• Company Name: AIRA, LLC
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810194404047 [Primary]
GS1	00810194404085 [Package]; Contains: 00810194404047; Package: 200pcs/bx,20bx/cs [4000 Units]; In Commercial Distribution
GS1	10810194404044 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071886

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00810194404085]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-08
• Device Publish Date: 2025-08-29

On-Brand Devices [Aira]

• 00810194400490: Aira Purguard - Nitrile Gloves, Pink, Xlarge, 100 Ea/Bx, 10 Bx/Ca, 1000 units total
• 00810194400483: Aira Purguard - Nitrile Gloves, Pink, Large, 100 Ea/Bx, 10 Bx/Ca, 1000 Units Total
• 00810194400476: Aira Purguard - Nitrile Gloves, Pink, Medium, 100 Ea/Bx, 10 Bx/Ca, 1000 Units total
• 00810194400469: Aira Purguard - Nitrile Gloves, Pink, Small, 100 Ea/Bx, 10 Bx/Ca, 1000 Units total
• 00810194400452: Aira Purguard - Nitrile Gloves, Pink, xsmall, 100/Bx, 10 Bx/Ca, 1000 Units Total
• 00810194400421: Aira Purguard - Nitrile Gloves, Blue, Medium, 300 Ea/Bx, 10 Bx/Ca, 3,000 units total
• 00810194400414: Aira Purguard - Nitrile Gloves, Blue, Small, 300 Ea/Bx, 10 Bx/Ca, 1000 units total
• 00810194400339: AIRA PURGUARD - Nitrile Gloves, Black, Large, 100/Bx, 10 Bx/Ca, 1000 Units total
• 00810194400322: AIRA PURGUARD - Nitrile Gloves, Black, Medium 100/Bx, 10 Bx/Ca, 1000 units total
• 00810194400315: AIRA PURGUARD - Nitrile Gloves, Black, Small 100/bx, 10 bx/ca, 100 units total
• 00810194400308: AIRA PURGUARD - Nitrile Gloves, Black, Xsmall, 100/bx, 10 bx/ca, 1000 units total
• 00810194400261: Aira Purguard - Nitrile Gloves, Blue, Small, 100 Ea/Bx, 10 Bx/Ca, 1000 Units total
• 00810194400254: Aira Purguard - Nitrile Gloves, Blue, Xsmall, 100 Ea/Bx, 10 Bx/Ca, 1000 units in total
• 00810194404108: 8" x 13" - Paper/Blue Film Self-Sealing Sterilization Pouch
• 00810194404092: 5.25" X 7.5" - Paper/Blue Film Self-Sealing Sterilization Pouch
• 00810194404085: 3.25" x 11" - Paper/Blue Film Self-Sealing Sterilization Pouch
• 00810194404078: 1.375" x 4.375" - Paper/Blue Film Self-Sealing Sterilization Pouch
• 00810194400957: 9" x 15" - Paper/Blue Film Self-Sealing Sterilization Pouch
• 00810194400889: 5.25" x 6.5" - Paper/Blue Film Self-Sealing Sterilization Pouch
• 00810194400872: 2.75" x 9" - Paper/Blue Film Self-Sealing Sterilization Pouch
• 00810194400865: 2.25" x 4" - Paper/Blue Film Self-Sealing Sterilization Pouch
• 00810194400834: 3.50 x 9 - Paper/Blue Film Self-Sealing Sterilization Pouch
• 00810194400827: 3.50" x 10" - Paper/Blue Film Self-Sealing Sterilization Pouch
• 00810194400803: 2.75" x 10" Paper/Blue Film Self-Sealing Sterilization Pouch
• 00810194400797: 2.25 x 5 Paper/Blue Film Self-sealing Sterilization Pouch
• 00810194400780: 3.50" x 5.5" - Paper/Blue Self-Sealing Sterilization Pouch
• 00810194400773: 5.25" x 11" - Paper/Clear Film Self-Sealing Sterilization Pouch