FDA.reportPublic FDA data

SmartPractice

Primary DI
00854498007115
Brand
SmartPractice
Company
Smarthealth, Inc.
Model
AL71300
Catalog number
AL71300
Device description
allergEAZE Clear Patch Test Chambers, 100X10
Published
2020-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103409000ALLERGEAZE R CLEARSmartpractice2011-03-15KXF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854498007115PrimaryGS10
10854498007112Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854498007115008544980071158544980071150854498007115
1085449800711210854498007112

GMDN Terms#

Term, Definition table
TermDefinition
Allergy testing adhesive strip, epicutaneousA band of adhesive material designed to be used for epicutaneous allergy testing. The device typically consists of a central portion containing a series of transparent discs onto which are applied potentially allergenic substances; it includes on one side a hypoallergenic pressure-sensitive adhesive for application to the skin of the patient. The device may include additional strips that can be used for labelling, to aid diagnosis of skin reactions. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-878-3837info@smartpractice.com

Regulatory Flags#

DUNS number
061081477
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D766406011SmartPractice40601406012016-09-08
D766SP6200181SmartPracticeSP620018SP6200182016-09-08
D766SP6200191SmartPracticeSP620019SP6200192016-09-08
00854498007108SmartPracticeAL71200AL712002020-12-02
00854498007146SmartPracticeAL7005AL70052020-12-02
00854498007153SmartPracticeAL7001AL70012020-12-02
00854498007160SmartPracticeAL7001PPAL7001PP2020-12-02
00854498007177SmartPracticeAL7002AL70022020-12-02
00854498007191SmartPracticeAL7000AL70002020-12-02
00854498007221SmartPracticeAL7003PPAL7003PP2020-12-02
00854498007245SmartPracticeAL7110AL71102020-12-15
00854498007269SmartPracticeAL7120PPAL7120PP2020-12-15
00854498007337SmartPracticeAL7004PPAL7004PP2020-12-02
00854498007344SmartPracticeAL7014AL70142020-12-02
00854498007351SmartPracticeAL7014PPAL7014PP2020-12-02
00854498007368SmartPracticeAL7100AL71002020-12-15
00854498007375SmartPracticeAL7210AL72102020-12-15
00854498007382SmartPracticeAL7220AL72202020-12-15
00854498007405SmartPracticeAL7201AL72012020-12-15
00854498007481SmartPracticeAL7012AL70122020-12-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327680720Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
10889483563274BALLARD™SUNMED, LLCKXF2025-11-17
10889483563298BALLARD™SUNMED, LLCKXF2025-11-17
10889483563328BALLARD™SUNMED, LLCKXF2025-11-17
10889483563342BALLARD™SUNMED, LLCKXF2025-11-17
10889483565520BALLARD™SUNMED, LLCKXF2025-11-17
10889483565537BALLARD™SUNMED, LLCKXF2025-11-17
10889483565544BALLARD™SUNMED, LLCKXF2025-11-17
M220761002Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXF2025-09-11
D832600BA4001MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
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10840330701454ProCureTwin Med, LLCKXF2024-11-14
10840330701461ProCureTwin Med, LLCKXF2024-11-14
10840330701478ProCureTwin Med, LLCKXF2024-11-14
10840330701485ProCureTwin Med, LLCKXF2024-11-14
00616784430713"DynaSafety Cotton-Tipped Applicators in Sealed Vial,3"""Dynarex CorporationKXF2024-11-11
00087701406973Good NeighborU.S. COTTON, LLCKXF2024-07-30
00817522013377SwabezeKENTEC MEDICAL, INC.KXF2024-06-28
00817522013353SwabezeKENTEC MEDICAL, INC.KXF2024-06-27
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00817522013384SwabezeKENTEC MEDICAL, INC.KXF2024-06-27
10817522013343SwabezeKENTEC MEDICAL, INC.KXF2024-06-20