FDA.reportPublic FDA data

Marketlab Inc

Primary DI
00817517020038
Brand
Marketlab Inc
Company
MARKETLAB INC.
Model
0067
Catalog number
0067
Device description
SafeCrit Sodium Heparin 40mm - 100/pk
Published
2018-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
00817517020038PrimaryGS10
00817517020908Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817517020038008175170200388175170200380817517020038
00817517020908008175170209088175170209080817517020908

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube IVD, sodium heparinA non-sterile glass or plastic collection tube containing the anticoagulant sodium heparin, 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

Contacts#

Phone, Email table
PhoneEmail
+1(866) 237-3722service@marketlabinc.com

Regulatory Flags#

DUNS number
848917027
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817518024523MarketLab, Inc.1087812025-12-18
00817643023972Hopkins1380422024-02-02
00817517027938Marketlab-Clinton1387632024-02-02
00817517027945Marketlab-Clinton1387642024-02-02
00817517027952Marketlab-Clinton1387652024-02-02
00817517027969Marketlab-Clinton1387662024-02-02
00817517027976Marketlab-Clinton1387672024-02-02
00817517027983Marketlab-Clinton1387682024-02-02
00817517027990Marketlab-Clinton1387692024-02-02
00817517028003Marketlab-Clinton1387702024-02-02
00817517028072Marketlab-Clinton1387712024-02-02
00817517028089Marketlab-Clinton1387722024-02-02
00817517028096Marketlab-Clinton1387732024-02-02
00817517028102Marketlab-Clinton1387742024-02-02
00817517028119Marketlab-Clinton1387752024-02-02
00817517028126Marketlab-Clinton1387762024-02-02
00817517028133Marketlab-Clinton1387772024-02-02
00817517028140Marketlab-Clinton1387782024-02-02
00817517028157Marketlab-Clinton1387792024-02-02
00817517028164Marketlab-Clinton1387802024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04086000860444CompoSeal Mobilea IIFresenius Kabi AGGHY2022-11-07
00664816002131LW Scientific, Inc.LW SCIENTIFIC, INC.GHY2020-06-30
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
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