FDA.reportPublic FDA data

CompoSeal Mobilea II

Primary DI
04086000860444
Brand
CompoSeal Mobilea II
Company
Fresenius Kabi AG
Model
9027011
Catalog number
9027011
Device description
The CompoSeal Mobilea II is intended to be used to seal medical PVC tubing hermetically and create break-off point.
Published
2022-11-07
Public version status
New
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
04086000860444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04086000860444040860008604444086000860444

GMDN Terms#

Term, Definition table
TermDefinition
Basic crimperA hand-held manual device designed to compress (pinch) a non-patient-contact sealing device (e.g., a clip or crimping ring of metal applied apart from the body) to reduce its size (diameter) and create a tight seal on objects being clamped or held together. This is performed by the application of force on the grip of the crimper's handles by the operator. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Transp. and storage Cond.: Temperature: -20°C - +70°C Rel. Air Hum: 30-75% Air-Pressure: 500-1060 hPa

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315654579
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811505030573IvenixSET-0040-1SET-0040-12026-06-02
00811137013104Amicus Separator6R4590R6R4590R2026-03-11
00810020442229Amicus MNC Apheresis Kit - Double NeedleX7R2326SBX7R2326SB2026-02-03
01081002044222Amicus MNC Apheresis Kit - Double NeedleX7R2326SBX7R2326SB2026-02-03
04086000860888COMPOGUARD Advance Basic902974190297412024-10-30
04086000860895COMPOGUARD Advance Data902975190297512024-10-29
04086000860901COMPOGUARD Advance COMPLETE902976190297612024-10-29
04086000860741CompoGuard Basic (NA)902964190296412022-11-10
04086000860758CompoGuard Data (NA)902965190296512022-11-10
04086000860765CompoGuard Complete (NA)902966190296612022-11-10
04086000100199ALYX 2RBC LR KITX4R5720X4R57202018-02-14
04086000100991Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed4R23674R23672016-09-09
04086000100984Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed4R23654R23652016-09-09
00810020440164AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly4R2353G4R2353G2020-10-20
04086000101370Fenwal AMICUS Single Needle Advanced Kit4R23534R23532016-09-02
04086000101387Fenwal AMICUS Double Needle Advanced Kit4R23544R23542016-09-02
00810020440140AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly4R2354G4R2354G2020-10-20
04086000101332Fenwal AMICUS Apheresis Kit - Double Needle4R23554R23552016-09-09
04086000101349Fenwal AMICUS Apheresis Kit - Single Needle4R23574R23572016-09-09
04086000100090AMICUS Apheresis Kit – Single NeedleX6R2312X6R23122025-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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