FDA.report

Maddox Defense / MACS

Primary DI
10850038889125
Brand
Maddox Defense / MACS
Company
Maddox Defense Inc.
Model
ABDL2-XL-US
Device description
Disposable Isolation Gown with SMS Material - AAMI PB70 Level 2 - X-Large
Published
2022-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications

CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10850038889125PackageGS1100In Commercial Distribution
00850038889128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003888912510850038889125
00850038889128008500388891288500388891280850038889128

GMDN Terms

TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods

Method

Regulatory Flags

DUNS number
969785539
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
true
Expiration date on label
true
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 DIBrandModelCatalogPublished
10850038889118Maddox Defense / MACS ABDL2-L-US 2022-07-28
10850038889132Maddox Defense / MACS ABDL2-99L-US 2022-07-28
10850038889149Maddox Defense / MACS ABDL2-99XL-US 2022-07-28
10850038889002Maddox DefenseMDSurg3-S 2022-03-14
10850038889019Maddox DefenseMDSurg3-M2022-03-14
10850038889026Maddox DefenseMDSurg3-L2022-03-14
10850038889033Maddox DefenseMDSurg3-XL2022-03-14
10850038889040Maddox DefenseMDSurg3-XXL2022-03-14
10850038889057Maddox DefenseMDSurg4-S2022-03-14
10850038889064Maddox DefenseMDSurg4-M2022-03-14
10850038889071Maddox DefenseMDSurg4-L2022-03-14
10850038889088Maddox DefenseMDSurg4-XL2022-03-14
10850038889095Maddox DefenseMDSurg4-XXL2022-03-14

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10080196163885MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
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10884389110010MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110072MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
00634916797114Reusable Gown STANDARD TEXTILE CO., INC.OEA2026-03-11
00634916797121Reusable GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916797459ComPel Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916881356Reversible Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916881363Reversible Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
10810132044356HCSConcordance Healthcare Solutions LLCOEA2026-03-09
20810132044360HCS SourcingConcordance Healthcare Solutions LLCOEA2026-03-09
40080196765523MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-05
10197344158881MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
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10197344158966MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
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10197344159123MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344200474MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03