FDA.reportPublic FDA data

Hematocrit capillaries

Primary DI
04050674019279
Brand
Hematocrit capillaries
Company
Andreas Hettich GmbH & Co. KG
Model
2074
Catalog number
2074
Device description
Hematocrit capillaries
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
04050674019279PackageGS110Not in Commercial Distribution
04050674084833PrimaryGS10
04050674085045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050674019279040506740192794050674019279
04050674084833040506740848334050674084833
04050674085045040506740850454050674085045

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

Regulatory Flags#

DUNS number
316403245
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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