FDA.reportPublic FDA data

ICU Medical

Primary DI
10887709023748
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
Z1646
Device description
88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave®, Rotating Luer w/Filter Cap
Published
2017-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation ValveGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709023748PackageGS125In Commercial Distribution
00887709023741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770902374810887709023748
00887709023741008877090237418877090237410887709023741

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion setA sterile, intravascular administration set used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
true
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709188720BivonaAT26CS50NSA182N2026-03-24
10887709188737BivonaAT26CS40NSA180N2026-03-24
10887709188744BivonaAT26CS40NSA181N2026-03-24
10887709188751BivonaAT26CS50NSA183N2026-03-24
10887709188836BivonaSU26CN45NGF194N2026-03-24
10887709188843BivonaSU26CN50NGF193N2026-03-24
10887709188850BivonaFT26CN65NSC192N2026-03-24
10887709188874BivonaFT26CN40NGE196N2026-03-24
10887709188881BivonaFT26CN50NSA199N2026-03-24
10887709188904BivonaHF26CS80NSC198N2026-03-24
10887709188805BivonaSU26CN55NGF1902026-03-23
10887709188812BivonaSU26CN60NSC189N2026-03-23
10887709188829BivonaXT26CS70NSC191N2026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859915300017N/ATIANYI MEDICAL(THAILAND) LIMITEDFJK2026-01-01
108408611025155008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025225008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025395008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025535008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025605008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611026075008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611026215008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
40383790011875SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
40383790011882NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
40383790011899NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
40383790011905NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
00850001011259Tablo(R) CartridgeOUTSET MEDICAL, INC.FJK2024-05-21
00850001011273Tablo(R) CartridgeOUTSET MEDICAL, INC.FJK2024-01-22
10840861102409CombiSetFresenius Medical Care Holdings, Inc.FJK2023-10-19
04046955776016Hemodialysis BloodlinesB. BRAUN MEDICAL INC.FJK2023-03-06
10850001011218Tablo(R) CartridgeOutset Medical, Inc.FJK2022-04-11
00850001011242Tablo(R) CartridgeOutset Medical, Inc.FJK2022-04-11
16948082709774NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2022-01-01
16948082709781NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2022-01-01
10887709021980ICU MedicalICU MEDICAL, INC.FJK2021-08-29
10887709027517ICU MedicalICU MEDICAL, INC.FJK2021-08-29
10887709076409ICU MedicalICU MEDICAL, INC.FJK2021-08-29
10887709028019ICU MedicalICU MEDICAL, INC.FJK2021-07-27
04046955735280Hemodialysis BloodlinesB. BRAUN MEDICAL INC.FJK2021-07-25
05060497260016SC+ Haemodialysis SystemQUANTA DIALYSIS TECHNOLOGIES LIMITEDFJK2021-06-21
05060497260030SC+ Haemodialysis SystemQUANTA DIALYSIS TECHNOLOGIES LIMITEDFJK2021-06-21
37332414004096BLOOD CIRCUIT SETBAXTER HEALTHCARE CORPORATIONFJK2021-05-13
16948082702102NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2021-03-15
16948082702119NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2021-03-15