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
10887709194585BivonaFU26EN60NGA202S2026-06-03
10887709194615BivonaFT26EN50NGA210N2026-06-03
10887709194790BivonaFT26FN35NGE013N2026-06-03
10887709194806BivonaFT26FN35NGF014N2026-06-03
10887709194813BivonaHU26FS50NGF016N2026-06-03
10887709194820BivonaFT26FN45NSA017N2026-06-03
10887709194837BivonaFT26FN30NSF018N2026-06-03
10887709194844BivonaFT26FN35NGE020N2026-06-03
10887709194851BivonaFT26FN30NSE021N2026-06-03
10887709194868BivonaSU26FN50NGF022N2026-06-03
10887709194875BivonaFT26FN35NSF023N2026-06-03
10887709194882BivonaHU26FS45NSB015N2026-06-03
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02
10887709194677BivonaST26EN60NTB206N2026-06-02
10887709194684BivonaST26EN60NTB207N2026-06-02
10887709194691BivonaST26EN55NTB208N2026-06-02
10887709194707BivonaST26EN55NTB209N2026-06-02
10887709194714BivonaFP26FN40NSA005N2026-06-02
10887709194721BivonaFU26FN35NSA006N2026-06-02

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