FDA.report

Uline ANSI Approved First Aid Kit - Class A, 25 Person

Primary DI
10851253007646
Brand
Uline ANSI Approved First Aid Kit - Class A, 25 Person
Company
ULINE, INC.
Model
H-6469
Catalog number
H-6469
Device description
"(2) ABSORBENT COMPRESS (10) ANTIBIOTIC OINTMENT (10) ANTISEPTIC TOWELETTES (10) BURN CREAM (1) BURN DRESSING (1) CPROTECTOR (8) EYE PAD WITH TAPE (1) FIRST AID FACTS GUIDE (1) FIRST AID TAPE (4) GAUZE PADS (1) GAUZE ROLL (10) HAND SANITIZER (1) INSTANT ICE PACK (2) NITRILE GLOVES (16) PLASTIC BANDAGES (1) SCISSORS (1) SINGLE USE SALINE (1) TRIANGULAR BANDAGE"
Published
2019-01-18
Public version status
Update
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
IMDPack, Hot Or Cold, Disposable
LRRFirst Aid Kit With Drug

Product Code Classifications

CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1
LRRFirst Aid Kit With DrugUnknownN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10851253007646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1085125300764610851253007646

GMDN Terms

TermDefinition
Endothermic cold therapy packA device intended to be applied with pressure to the body surface to provide cold therapy to help reduce fever, pain, and inflammation associated with joint/muscle/tissue injury and/or minor burns. It typically consists of a compact envelope made of plastic and filled with chemicals that generate an endothermic chemical reaction when activated to reduce the temperature of the pack. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
039612668
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
false
Sterilization required before use
false

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30850015055530ULINE BULLET EARPLUGS - CORDEDS-179032024-07-23
30850015055547ULINE BELL EARPLUGS - UNCORDEDS-221402024-07-23
30850015055554ULINE BELL EARPLUGS - CORDEDS-221412024-07-23
30850015055493ULINE BULLET EARPLUGS REFILLS-259462024-05-13
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10850015055604CPR OR SPRAINS TREATMENT PACKS-256172024-01-29
10850015055611BLEEDING CONTROL TREATMENT PACKS-256182024-01-29
10850015055628WOUND CARE TREATMENT PACKS-256192024-01-29
10850015055635BURN CARE TREATMENT PACKS-256202024-01-29
10850015055642BLOODBORNE PATHOGEN SPILL TREATMENT PACKS-256212024-01-29
10850015055659EYE CARE TREATMENT PACKS-256222024-01-29
30850015055455SAFE-FLEX 6 MIL NITRILE EXAM - LS-21573-L2024-01-29

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