FDA.reportPublic FDA data

Aira

Primary DI
00810194400810
Brand
Aira
Company
AIRA, LLC
Model
100522
Device description
3.50" x 5.25" Paper/Blue Film Self-Sealing Sterilization Pouch - 200/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
00810194400810PackageGS16000In Commercial Distribution
00810194400544PrimaryGS10
10810194400541Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810194400810008101944008108101944008100810194400810
00810194400544008101944005448101944005440810194400544
1081019440054110810194400541

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
200
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
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
00810194400018Aira1191312025-07-16
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
00810194400643Aira1005332026-02-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842942013065PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013072PRIMEDpriMED Medical Products IncFRG2026-05-29
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00842942013102PRIMEDpriMED Medical Products IncFRG2026-05-29
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00842942013225PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013232PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013249PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013256PRIMEDpriMED Medical Products IncFRG2026-05-29
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00842942013447PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013454PRIMEDpriMED Medical Products IncFRG2026-05-29
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00842942013607PRIMEDpriMED Medical Products IncFRG2026-05-29
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00842942013621PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013638PRIMEDpriMED Medical Products IncFRG2026-05-29