FDA.reportPublic FDA data

LW Scientific, Inc.

Primary DI
00664816002131
Brand
LW Scientific, Inc.
Company
LW SCIENTIFIC, INC.
Model
CNT-ZPC7-40HE
Catalog number
CNT-ZPC7-40HE
Device description
Hematocrit tubes, Glass, Plain, 200/vial, 40mm, for ZIP Combo microhematocrit.
Published
2020-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GHYHematocrit, Tube, Rack, Sealer, Holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHYHematocrit, Tube, Rack, Sealer, HolderHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00664816002131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00664816002131006648160021316648160021310664816002131

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube, no additiveA non-sterile glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection, This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
785335381
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00664816005897Qor LabsQLL-HRSD-10T3QLL-HRSD-10T32026-04-20
00664816005903Qor LabsQLL-HRDD-20T3QLL-HRDD-20T32026-04-20
00664816005316LW Scientific, Inc.Z4M-BZM7-EML3Z4M-BZM7-EML32026-04-17
00664816005323LW Scientific, Inc.Z4M-TZM7-EML3Z4M-TZM7-EML32026-04-17
00664816006030LW Scientific, Inc`E8C-C8AF-150PE8C-C8AF-150P2026-03-02
00664816006016LW ScientificM5C-BKT8-50A1M5C-BKT8-50A12026-02-20
00664816002322LW Scientific, IncICL-030L-D101ICL-030L-D1012026-02-19
00664816005682LW Scientific, Inc.MUC-08AT-15T3MUC-08AT-15T32026-02-16
00664816005699LW Scientific, Inc.DBL-40PL-02DPDBL-40PL-02DP2026-02-16
00664816005866LW Scientific, Inc.ROM-BN4A-IPL3ROM-BN4A-IPL32025-10-20
00664816005873LW Scientific, Inc.ELM-BN4A-IPL3ELM-BN4A-IPL32025-10-20
00664816005934LW Scientific, Inc.ROM-TN4A-IPL3ROM-TN4A-IPL32025-10-20
00664816005941LW Scientific, Inc.ELM -TN4A-IPL3ELM -TN4A-IPL32025-10-20
00664816005958LW Scientific, Inc.ASM-BN4A-IPL3ASM-BN4A-IPL32025-10-20
00664816005965LW Scientific, Inc.ASM-TN4A-IPL3ASM-TN4A-IPL32025-10-20
00664816001400LW Scientific, Inc.SHL-PPF7-06F1SHL-PPF7-06F12021-04-09
00664816003756LW Scientific, Inc`MMC-12MD-02T1MMC-12MD-02T12024-07-01
00664816005842LW Scientific, Inc.FWL-TISS-BTH3FWL-TISS-BTH32024-06-28
00664816005835LW ScientificZIC-06AD-15P3ZIC-06AD-15P32024-06-13
00664816001431LW Scientific, Inc.WBL-20LC-SSD1WBL-20LC-SSD12021-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04086000860444CompoSeal Mobilea IIFresenius Kabi AGGHY2022-11-07
00664816003671LW Scientific, Inc.LW SCIENTIFIC, INC.GHY2020-01-22
00840095607513Globe ScientificGLOBE SCIENTIFIC INC.GHY2019-11-26
0086000102402975mm Self-Sealing Capillary TubesDRUMMOND SCIENTIFIC COMPANYGHY2019-08-01
0086000102403675mm Plastic-crit PlainDRUMMOND SCIENTIFIC COMPANYGHY2019-07-19
0086000102404375mm Plastic-crit HeparinizedDRUMMOND SCIENTIFIC COMPANYGHY2019-07-19
0086000102400575mm Hemato-clad PlainDRUMMOND SCIENTIFIC COMPANYGHY2019-05-01
0086000102401275mm Hemato-clad HeparinizedDRUMMOND SCIENTIFIC COMPANYGHY2019-05-01
00817517020014Marketlab IncMARKETLAB INC.GHY2018-11-16
00817517020021Marketlab IncMARKETLAB INC.GHY2018-11-16
00817517020038Marketlab IncMARKETLAB INC.GHY2018-11-16
00817517020045Marketlab IncMARKETLAB INC.GHY2018-11-16
04050674084833Hematocrit capillariesAndreas Hettich GmbHGHY2016-09-24
04050674019262Sealing Putty for hematocrit capillariesAndreas Hettich GmbHGHY2016-09-24
04050674019279Hematocrit capillariesAndreas Hettich GmbH & Co. KGGHY2016-09-24
10643351000373SAFE-T-FILL®Ram Scientific, IncGHY2016-09-15
10643351000380SAFE-T-FILL®Ram Scientific, IncGHY2016-09-15
10643351000397SAFE-T-FILL®Ram Scientific, IncGHY2016-09-15
30643351000384SAFE-T-FILL®Ram Scientific, IncGHY2016-09-15
30643351000377SAFE-T-FILL®Ram Scientific, IncGHY2016-09-15
30643351000391SAFE-T-FILL®Ram Scientific, IncGHY2016-09-15