FDA.reportPublic FDA data

ICU Medical

Primary DI
10887709123592
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
OTC
false
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.

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

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
00887709123595ICU 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