Aira

GUDID 00810194402708

Earloop 3-PLY Masks 50/Bx ASTM 3 Pink BFE=>98, PFE=>98, Synthetic Blood 160 mmHg - 50/bx, 40 bx/cs (2000 pcs/Cs)

AIRA, LLC

Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 00810194402708
• NIH Device Record Key: 69943241-26d1-41bb-b70c-f3cf9b42ac18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aira
• Version Model Number: 109131
• Company DUNS: 137437162
• Company Name: AIRA, LLC
• Device Count: 50
• 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	00810194402609 [Primary]
GS1	00810194402708 [Package]; Contains: 00810194402609; Package: Case [2000 Units]; In Commercial Distribution
GS1	10810194402606 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220512

FDA Product Code

• FXX: Mask, Surgical

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: 2026-01-26
• Device Publish Date: 2026-01-16

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
• 10810194403979: Ultrasonic Cleaning Tablets 64pcs/Bx - 10 Bx/CS
• 00810194402708: Earloop 3-PLY Masks 50/Bx ASTM 3 Pink BFE=>98, PFE=>98, Synthetic Blood 160 mmHg - 50/bx, 40 bx
• 00810194402692: Earloop 3-PLY Masks 50/Bx ASTM 3 Blue, Synthetic Blood 160 mmHg - 50pcs/Box, 40 Bx/Cs (2000 pcs/
• 00810194402678: Earloop 3-PLY Masks 50/Bx ASTM 2 Blue, Synthetic Blood 120 mmHg - 50/Bx, 40 Bx/Cs (2000 pcs/Cs)
• 00810194401855: Gauze - Non-Woven, 4 x 4, N/S 4-Ply - 200/Bx, 10Bx/Cs (2000 Pcs/Cs)
• 00810194401848: Premium - Gauze - Non-Woven, 2 x 2, N/S 4-Ply - 200/Bx, 25 Bx/Cs (5000/Cs)
• 00810194401831: Gauze - Non-Woven, 3 x 3, N/S 4-Ply - 200 pcs/Bx, 20 Bx/Cs (4000 pcs/Cs)
• 00810194401824: Gauze - Woven, 2x2, STERILE, 12ply, Individually wrapped, 100/BX - 24box/case (2400 Pcs/Cs)
• 00810194401794: Cotton Rolls - #2 - 2000pcs/Bx, 6 Bx/Cs (12,000 pcs/Cs)
• 00810194401787: Gauze - Non-Woven, 2 x 2, STERILE, 8-Ply - 100/Bx, 50 Bx/Cs (5000/Cs)
• 00810194401770: Gauze - Non-Woven, 2 x 2, N/S 4-Ply - 200 pcs/Bx, 20 Bx/Cs (4000/Cs)
• 00810194401763: Gauze - Non-Woven, 2 x 2, N/S 4-Ply - 200/Bx, 25 Bx/CS (5000pcs/Cs)
• 00810194401022: 5.25" x 10" - Paper/Blue Film Self-Sealing Sterilization Pouch, Bulk Pack - 500/Bx, 6 Bx/Cs (300
• 00810194400964: 7.50" x 13"- Paper/Blue Film Self-Sealing Sterilization Pouch - 200 pcs/Bx. 10 Bx/Cs (2000 pcs/C
• 00810194400933: 3.50" x 5.75" - Paper/Blue Film Self-Sealing Sterilization Pouch - 200/Bx, 30 Bx/Cs (6000 pcs/Cs
• 00810194400896: 10" x 15"- Paper/Blue Film Self-Sealing Sterilization Pouch - 200/Bx, 5 Bx/Cs (1000 pcs/Cs)
• 00810194400445: Nitrile Gloves X-Large - 250/Bx, 10 Bx/Cs (2500 pcs/Cs)
• 00810194400391: Nitrile Gloves X-Large - 200/Bx, 10 Bx/Cs (2000 pcs/cs)
• 00810194400377: Nitrile Gloves Medium 200/Bx, 10 Bx/Cs (2000 pcs/Cs)
• 00810194400360: Nitrile Gloves Small - 200/Bx, 10 Bx/Cs (2000 pcs/Cs)
• 00810194400353: Nitrile Gloves X-small - 200pcs/Bx, 10 Bx/Cs (2000 pcs/Cs)