FDA.reportPublic FDA data

Aira

Primary DI
00810194401893
Brand
Aira
Company
AIRA, LLC
Model
108500
Device description
Hemostatic Dressing Gauze 20/Bx - (Gelfoam comparable)
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810194401893PackageGS1200In Commercial Distribution
00810194401756PrimaryGS10
10810194401753Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810194401893008101944018938101944018930810194401893
00810194401756008101944017568101944017560810194401756
1081019440175310810194401753

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobialA non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
137437162
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810194400018Aira1191312025-07-16
00810194400148Aira1192042026-01-16
00810194400193Aira1193042026-01-16
00810194401756Aira1085002026-03-13
00810194400605Aira1005292025-08-29
00810194400049Aira1191342026-03-10
00810194402616Aira1091322026-03-10
00810194402647Aira1091352026-03-10
10810194400046Aira1191342026-03-10
00810194402715Aira1091322026-03-10
00810194402746Aira1091352026-03-10
00810194400025Aira1191322026-02-10
00810194400032Aira1191332026-02-10
00810194400094Aira1191442026-02-10
00810194400155Aira1193002026-02-10
00810194400186Aira1193032026-02-10
00810194400544Aira1005222026-02-10
00810194400575Aira1005252026-02-10
00810194400582Aira1005262026-02-10
00810194400636Aira1005322026-02-10

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Primary DI, Brand, Company table
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10841495149495QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149501QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149518QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149549QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149563QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149587QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149600QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
10841495149624QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930644QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930651QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
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14026704930675QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930682QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930699QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930705QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930729QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930736QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930743QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930750QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930767QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930774QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930781QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930798QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930804QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
14026704930811QUIKCLOTTELEFLEX INCORPORATEDQSY2026-07-17
06970206822390Rhino Rescue Hemostatic DressingJiangsu NewValue Medical Products Co.,Ltd.QSY2026-06-22