FDA.reportPublic FDA data

ICU Medical

Primary DI
00887709123595
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
011-CGHD-100
Catalog number
011-CGHD-100
Device description
ClearGuard® HD
Published
2024-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PEHHemodialysis Catheter Luer End Cap

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEHHemodialysis Catheter Luer End CapGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180111000ClearGuard HD Antimicrobial Barrier CapPursuit Vascular, Inc.2018-05-25PEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709123592PackageGS1100In Commercial Distribution
00887709123595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770912359210887709123592
00887709123595008877091235958877091235950887709123595

GMDN Terms#

Term, Definition table
TermDefinition
Luer-formatted disinfection capA small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709195131BivonaST26FN50NGF055N2026-06-08
10887709195148BivonaFT25LN30NGF157N2026-06-08
10887709195155BivonaFT26FN35NSF050N2026-06-08
10887709195162BivonaHT26FS45NGF051N2026-06-08
10887709195179BivonaFT26FN40NGF053N2026-06-08
10887709195186BivonaFT26FN35NGF054N2026-06-08
10887709195193BivonaFU26FN45NGF049N2026-06-08
10887709195209BivonaFT26FN60NGA046N2026-06-08
10887709195216BivonaFT26FN35NGE057N2026-06-08
10887709195223BivonaFT26FN30NGE056N2026-06-08
10887709195230BivonaFP26FN40NGC058N2026-06-08
10887709195247BivonaFT26FN35NSF059N2026-06-08
10887709195254BivonaFT26FN40NGE063N2026-06-08
10887709195261BivonaXT26FS60NGC064N2026-06-08
10887709195278BivonaFU26FN45NSF052N2026-06-08
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709123592ICU MedicalICU MEDICAL, INC.PEH2024-01-18
B081CGHD109258247ClearGuard HDPursuit Vascular, Inc.PEH2022-09-30
B081CGHD109258246ClearGuard HDPursuit Vascular, Inc.PEH2022-09-29
B081CGHD109258245ClearGuard HDPursuit Vascular, Inc.PEH2022-09-28
B081CGHD109258244ClearGuard HDPursuit Vascular, Inc.PEH2022-09-27
B081CGHD109258243ClearGuard HDPursuit Vascular, Inc.PEH2022-09-26
B081CGHD109258242ClearGuard HDPursuit Vascular, Inc.PEH2022-09-23
B081CGHD109258241ClearGuard HDPursuit Vascular, Inc.PEH2022-09-22
B081CGHD109258240ClearGuard HDPursuit Vascular, Inc.PEH2022-09-21
B081CGHD109258239ClearGuard HDPursuit Vascular, Inc.PEH2022-09-20
B081CGHD109258238ClearGuard HDPursuit Vascular, Inc.PEH2022-09-19
B081CGHD109258237ClearGuard HDPursuit Vascular, Inc.PEH2022-09-16
B081CGHD109258236ClearGuard HDPursuit Vascular, Inc.PEH2022-09-15
B081CGHD109258235ClearGuard HDPursuit Vascular, Inc.PEH2022-09-14
B081CGHD109258234ClearGuard HDPursuit Vascular, Inc.PEH2022-09-13
B081CGHD109258233ClearGuard HDPursuit Vascular, Inc.PEH2022-09-12
B081CGHD1089258232ClearGuard HDPursuit Vascular, Inc.PEH2022-09-09
B081CGHD109258231ClearGuard HDPursuit Vascular, Inc.PEH2022-09-08
B081CGHD109258230ClearGuard HDPursuit Vascular, Inc.PEH2022-09-07
B081CGHD109258229ClearGuard HDPursuit Vascular, Inc.PEH2022-09-06
B081CGHD109258228ClearGuard HDPursuit Vascular, Inc.PEH2022-09-05
B081CGHD109258227ClearGuard HDPursuit Vascular, Inc.PEH2022-09-02
B081CGHD109258226ClearGuard HDPursuit Vascular, Inc.PEH2022-09-01
B081CGHD108258225ClearGuard HDPursuit Vascular, Inc.PEH2022-08-31
B081CGHD108258224ClearGuard HDPursuit Vascular, Inc.PEH2022-08-30
B081CGHD108258223ClearGuard HDPursuit Vascular, Inc.PEH2022-08-29
B081CGHD108258222ClearGuard HDPursuit Vascular, Inc.PEH2022-08-26
B081CGHD108258221ClearGuard HDPursuit Vascular, Inc.PEH2022-08-25
B081CGHD108258220ClearGuard HDPursuit Vascular, Inc.PEH2022-08-24
B081CGHD108258219ClearGuard HDPursuit Vascular, Inc.PEH2022-08-23