FDA.reportPublic FDA data

Aira

Primary DI
00810194400971
Brand
Aira
Company
AIRA, LLC
Model
100590
Device description
2.25" x 4" - Paper/Blue Film Self-Sealing Sterilization Pouch, Bulk Pack - 500/Bx - 30 bx/ca
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071886000SELF SEAL STERILIZATION POUCHShanghai Jianzhong Medical Packaging Co., Ltd.2007-12-27FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810194400971PackageGS115000In Commercial Distribution
00810194400704PrimaryGS10
10810194400701Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810194400971008101944009718101944009710810194400971
00810194400704008101944007048101944007040810194400704
1081019440070110810194400701

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
137437162
Device count
500
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
00810194401893Aira1085002026-03-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995241858V. MuellerSteris CorporationFRG2026-08-18
00724995241865V. MuellerSteris CorporationFRG2026-08-18
00724995241872V. MuellerSteris CorporationFRG2026-08-18
00724995241889V. MuellerSteris CorporationFRG2026-08-18
00840118614245Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614252Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614269Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614276Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614283Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614290Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614306Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
20680651497639HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497646HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497653HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497660HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497677HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497684HalyardO&M HALYARD, INC.FRG2026-07-16
00859464007731Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14
00859464007748Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14
08404535030761Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
08404535030792Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
00840456206881JMUJMU DENTAL, INCFRG2026-07-08
00840456206898JMUJMU DENTAL, INCFRG2026-07-08
00840456206928JMUJMU DENTAL, INCFRG2026-07-08
10686864061868MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061875MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061899MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061905MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061912MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061929MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25