FDA.reportPublic FDA data

SmartPractice

Primary DI
00854498007542
Brand
SmartPractice
Company
Smarthealth, Inc.
Model
AL925
Catalog number
AL925
Device description
patchPrep tray Starter Kit
Published
2020-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854498007542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854498007542008544980075428544980075420854498007542

GMDN Terms#

Term, Definition table
TermDefinition
General laboratory container, reusableA container (e.g., test tube, bottle, cup) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), biological specimens, and other materials associated with in the laboratory; it is not intended for in vitro diagnostic procedures. It is designed to withstand an extremely high-temperature environment (e.g., autoclaving) to enable repeated sterilization. It is typically made of high-temperature-resistant plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers (e.g., tissue culture). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
061081477
Device count
1
Premarket exempt
true
Kit
true
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
00854498007115SmartPracticeAL71300AL713002020-12-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590812478DxUBeckman Coulter, Inc.LXG2026-06-24
08435389828150SAMPLE PREPARATION KITBIOTECHNOLOGY INSTITUTE SLLXG2026-05-27
00816394021855Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021930Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021947Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021954Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021985Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021992Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022005Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022012Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022050Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022067Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022074Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022081Helmer ScientificHELMER, INC.LXG2026-05-13
15099590695743iChemVELOCITYBECKMAN COULTER IRELAND INC.LXG2026-04-27
09120123910022Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
26974573531033CellproSuzhou CellPro Biotechnology Co., Ltd.LXG2025-11-21
10818207025071Endocator Starter KitVista DentalLXG2025-11-07
10818207025088Endocator Swabs (20pk)Vista DentalLXG2025-11-07
10849832025815Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-23
10849832024238Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
10849832024276Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
10849832027055Leica BiosystemsLeica Biosystems Richmond, Inc.LXG2025-07-20
00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050283KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050306KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050511KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050528KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050535KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050542KBMEDKB Medical (group), Inc.LXG2025-05-22