FDA.reportPublic FDA data

SmartPractice

Primary DI
00854634003049
Brand
SmartPractice
Company
Smarthealth, Inc.
Model
AL7950
Catalog number
AL7950
Device description
TruVol 20 microliter Precision Allergen Dispenser, 20-pack
Published
2020-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JRCMicro Pipette

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRCMicro PipetteClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854634003049PrimaryGS10
10854634003046Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854634003049008546340030498546340030490854634003049
1085463400304610854634003046

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical micropipetteA manually-operated device typically used in the laboratory to withdraw, transfer, and inject minute volumes of fluid materials (e.g., microlitres or smaller). The device is typically hand-held and operates through an internal mechanism powered by finger depressions of the user; it can have a single channel or a multichannel piston/cylinder assembly. The device transfers consistent volumes of substance into one or several receptacles simultaneously. The device may be factory pre-set to deliver a given volume, or may have user-selectable volumes within a useful volume range.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
061081477
Device count
20
Premarket exempt
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
00875197007459cobas® Liat Transfer Pipette PackRoche Molecular Systems, Inc.JRC2026-03-26
10810050855799SmearsafeTYPENEX MEDICAL LLCJRC2025-10-13
04038917085830Haemo-Diff®Sarstedt Aktiengesellschaft & Co.KGJRC2025-09-25
00840095688840Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688857Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688864Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688871Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688888Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688895Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688901Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688918Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688925Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688932Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688949Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688956Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095688994Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689007Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689014Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689021Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689038Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689045Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689052Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689069Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689076Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689083Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689090Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689106Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689113Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689120Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07
00840095689137Globe Scientific GLOBE SCIENTIFIC INC.JRC2025-07-07