FDA.report

Medical Action Industries

Primary DI
20809160286125
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
78976
Published
2020-06-19
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
NSBPatient personal hygiene kit

Product Code Classifications

CodeDeviceSpecialtyClass
NSBPatient Personal Hygiene KitDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160286125PackageGS15In Commercial Distribution
10809160286128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916028612520809160286125
1080916028612810809160286128

GMDN Terms

TermDefinition
Personal care kitA collection of devices intended to be used by a patient for personal care needs during a stay in a healthcare institution. It typically contains items such as gown, slippers, cap, hair comb and toothbrush in a storage bag, and may also contain additional personal care products e.g., toothpaste, lotion and deodorant. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Sterilization Methods

Method

Regulatory Flags

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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

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20809160513856Medical Action Industries822742026-02-25
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20809160512521MEDICAL ACTION INDUSTRIES826092026-02-13
20809160512231MEDICAL ACTION INDUSTRIES846012026-02-11
20809160512248MEDICAL ACTION INDUSTRIES843142026-02-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20809160516574Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-03-19
20809160513856Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2026-02-25
20809160513337MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.NSB2026-02-20
57613327680732Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
57613327680749Q-CareSAGE PRODUCTS, LLCNSB2025-12-03
30889483565319BALLARD™SUNMED, LLCNSB2025-12-01
30889483565333BALLARD™SUNMED, LLCNSB2025-12-01
30889483565340BALLARD™SUNMED, LLCNSB2025-12-01
30889483565357BALLARD™SUNMED, LLCNSB2025-12-01
30889483565364BALLARD™SUNMED, LLCNSB2025-12-01
10889483565377BALLARD™SUNMED, LLCNSB2025-12-01
30889483565388BALLARD™SUNMED, LLCNSB2025-12-01
20809160492342Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2025-08-18
10661392000718LSL HEALTHCARELSL Industries, LLCNSB2025-05-16
10661392000824LSL HEALTHCARELSL Industries, LLCNSB2025-05-16
10661392003115LSL HEALTHCARELSL Industries, LLCNSB2025-05-16
10661392045153LSL HEALTHCARELSL Industries, LLCNSB2025-05-16
10661392054162LSL HEALTHCARELSL Industries, LLCNSB2025-05-16
10661392004853LSL HEALTHCARELSL Industries, LLCNSB2025-05-15
20809160450519Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2024-12-30
00850030081056OralKleenOralkleen, LLCNSB2024-09-12
20809160410285Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2023-10-19
20809160410292Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2023-10-19
20809160409739Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2023-10-06
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20809160400910Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.NSB2023-05-30
50618029830116Q-Care RxSAGE PRODUCTS, LLCNSB2023-05-08
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