FDA.reportPublic FDA data

Aero-Med

Primary DI
50810010892916
Brand
Aero-Med
Company
Aero-Med, Ltd.
Model
AM100PL-144
Catalog number
AM100-PL
Device description
Bandage Plastic 3/4X3IN STR LF
Published
2020-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape and bandage, adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30810010892912PackageGS1100In Commercial Distribution
50810010892916PackageGS114400In Commercial Distribution
00810010892911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081001089291230810010892912
5081001089291650810010892916
00810010892911008100108929118100108929110810010892911

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194550042
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50192253068748Aero-MedCA38075BCA38075B2025-05-01
50885380208308Aero-MedCA1500ACA1500A2025-04-18
50885380183667Aero-MedCA18750ACA18750A2025-04-15
50885380207721Aero-MedCA18725BCA18725B2025-04-15
50810010894729Aero-MedQUE3325QUE33252025-04-10
50885380207707Aero-MedCA38075BCA38075B2025-04-08
50885380207714Aero-MedCA38100BCA38100B2025-04-08
50885380208063Aero-MedCA14800BCA14800B2025-04-07
50885380198715Aero-MedCA54550CA545502024-01-08
50885380207745Aero-MedCA61875CA618752025-04-02
50885380198708Aero-MedCA32250BCA32250B2024-01-08
50885380207455Aero-MedCA61175CA611752025-03-20
50885380207677Aero-MedCA61900CA619002025-03-19
50810010894774Aero-MedAMM19300AMM193002025-03-06
50885380207363Aero-MedCA59025CA590252025-03-03
50885380207448Aero-MedCA59000CA590002025-03-03
50810010894736Aero-MedAMM18850AMM188502025-02-11
50810010894743Aero-MedAMM18875AMM188752025-02-11
50885380205536Aero-MedCA60225CA602252024-10-07
50885380206823Aero-MedCA60675CA606752025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628942588907Blistape Blistape IncKGX2026-03-10
00628942588983Blistape Blistape IncKGX2026-03-10
60041260026852KrogerKROGER CO., THEKGX2026-03-09
00819143026354HealquHealqu LLCKGX2026-03-05
00819143026453HealquHealqu LLCKGX2026-03-05
00861092002644Cealogic FilmRECIBIO, INC.KGX2026-03-01
50192253049815TelfaCardinal Health 200, LLCKGX2026-02-25
50192253050088TelfaCardinal Health 200, LLCKGX2026-02-25
30197344181654CURADMEDLINE INDUSTRIES, INC.KGX2026-02-23
00819143026309HealquHealqu LLCKGX2026-02-19
05715205000360Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205000407Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205000438Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205000469Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205100015Plum QuickSoftPlum Safety ApSKGX2026-02-17
05715205110014Plum QuickSoftPlum Safety ApSKGX2026-02-17
05715205120013Plum QuickSoftPlum Safety ApSKGX2026-02-17
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