FDA.reportPublic FDA data

Maddox Defense / MACS

Primary DI
10850038889118
Brand
Maddox Defense / MACS
Company
Maddox Defense Inc.
Model
ABDL2-L-US
Device description
Disposable Isolation Gown with SMS Material - AAMI PB70 Level 2 - 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

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850038889118PackageGS1100In Commercial Distribution
00850038889111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003888911810850038889118
00850038889111008500388891118500388891110850038889111

GMDN Terms#

Term, Definition table
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 table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850038889111Maddox Defense ABDL2-L-US 2022-07-28
00850038889128Maddox Defense ABDL2-XL-US 2022-07-28
00850038889135Maddox DefenseABDL2-99L-US 2022-07-28
00850038889142Maddox Defense ABDL2-99XL-US 2022-07-28
10850038889125Maddox Defense / MACS ABDL2-XL-US 2022-07-28
10850038889132Maddox Defense / MACS ABDL2-99L-US 2022-07-28
10850038889149Maddox Defense / MACS ABDL2-99XL-US 2022-07-28
00850038889005Maddox DefenseMDSurg3-S 2022-03-14
00850038889012Maddox DefenseMDSurg3-M2022-03-14
00850038889029Maddox DefenseMDSurg3-L2022-03-14
00850038889036Maddox DefenseMDSurg3-XL2022-03-14
00850038889043Maddox DefenseMDSurg3-XXL2022-03-14
00850038889050Maddox DefenseMDSurg4-S2022-03-14
00850038889067Maddox DefenseMDSurg4-M2022-03-14
00850038889074Maddox DefenseMDSurg4-L2022-03-14
00850038889081Maddox DefenseMDSurg4-XL2022-03-14
00850038889098Maddox DefenseMDSurg4-XXL2022-03-14
10850038889002Maddox DefenseMDSurg3-S 2022-03-14
10850038889019Maddox DefenseMDSurg3-M2022-03-14
10850038889026Maddox DefenseMDSurg3-L2022-03-14

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Primary DI, Brand, Company table
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10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
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10197106833490CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13