FDA.reportPublic FDA data

Fisherbrand

Primary DI
00613647029305
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
110911PL-FH
Catalog number
22170178
Device description
Fisherbrand™ Auto-AnalyzerSAMPLE CUP 3ML PS HIT M/PK
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGXTABLE, EXAMINATION, MEDICAL, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGXTable, Examination, Medical, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647029309PackageGS11In Commercial Distribution
00613647029305PrimaryGS10
10613647029302Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702930920613647029309
00613647029305006136470293056136470293050613647029305
1061364702930210613647029302

GMDN Terms#

Term, Definition table
TermDefinition
Assay container IVD, single-useA reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(724)517-1500regulatory.affairs@thermofisher.com

Regulatory Flags#

DUNS number
004321519
Device count
1000
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613647028346Fisherbrand11002204110022042025-06-30
00613647028674Fisherbrand13-711-274MD13711274MD2025-06-30
00613647028681Fisherbrand13-711-336MD13711336MD2025-06-30
00613647028698Fisherbrand13-711-5AMMD137115AMMD2025-06-30
00613647028711Fisherbrand13-711-9AMMD137119AMMD2025-06-30
20613647028340Fisherbrand11002204110022042025-06-30
20613647028678Fisherbrand13-711-274MD13711274MD2025-06-30
20613647028685Fisherbrand13-711-336MD13711336MD2025-06-30
30613647028699Fisherbrand13-711-5AMMD137115AMMD2025-06-30
30613647028712Fisherbrand13-711-9AMMD137119AMMD2025-06-30
00613647029855Fisherbrand121011F2141270512025-06-30
00613647029862Fisherbrand120953F141275542025-06-30
00613647010907FisherbrandSC-150-100135001002025-04-30
00613647010914FisherbrandSC-180-100135001012025-04-30
00613647010921FisherbrandSC-220-100135001022025-04-30
00613647010938FisherbrandSC-250-100135001032025-04-30
00613647018842Fisherbrand23101000231010002025-04-30
00613647018859Fisherbrand23101001231010012025-04-30
00613647018866Fisherbrand23101002231010022025-04-30
00613647018873Fisherbrand23101003231010032025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975582544010CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544027CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544034CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544041CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544058CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
00848871001500EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001517EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001524EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001531EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00670482001071Echo-Flex 5002Umano Medical IncLGX2026-02-18
04260647941524ak 5010 MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942040Additive Back support MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942057Additive Back support (viscoel.) MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942064Adapter footrest MBSAKRUS GmbH & Co. KGLGX2025-11-28
00667259004007Laguna Edge (2M)Silhouet-Tone CorporationLGX2025-11-12
00728564057000Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564057017Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564058007Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564058014Flex Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564060000Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564060017Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564065005Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564065012Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564068006Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564068013Access High-Low TableThe Brewer Company, LLCLGX2025-11-10
00728564157007Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564157014Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564158004Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564158011Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564160007Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10