ICU Medical

Primary DI
10887709021980
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
Z0877
Catalog number
Z0877
Device description
130" (330 cm) Y-Type Blood Set w/170 Micron Filter, 2 Y-Connectors w/Check Valves, Remv 3 Gang 1o2™ Manifold, Check Valve, Rotating Luer, 1 Ext
Published
2021-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983559000BLOOD TUBING ACCESSORY WITH CLAVE CONNECTORIcu Medical, Inc.1998-12-24FJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709021980PackageGS125In Commercial Distribution
00887709021983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770902198010887709021980
00887709021983008877090219838877090219830887709021983

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion set, non-exchangeAn intravascular administration set intended to be 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

Contacts#

Phone, Email table
PhoneEmail
+1(866)829-9025customerservice@icumed.com

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
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

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Primary DI, Brand, Model table
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10887709195087BivonaSU26FN35NGF041N2026-06-05
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10887709195100BivonaFT26FN25NGF044N2026-06-05
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10887709195124BivonaFU26FN70NTC048N2026-06-05
10887709194899BivonaFU26FN35NGE024N2026-06-04
10887709194905BivonaFT26FN40NGE027N2026-06-04
10887709194912BivonaFU26FN40NGE028N2026-06-04

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Primary DI, Brand, Company table
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04711552764048SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764086SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764758SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
08859915300017N/ATIANYI MEDICAL(THAILAND) LIMITEDFJK2026-01-01
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