FDA.reportPublic FDA data

ClearGuard™

Primary DI
00887709123588
Brand
ClearGuard™
Company
ICU MEDICAL, INC.
Model
CGHD-100
Catalog number
CGHD-100
Device description
ClearGuard™ HD 100 Pack
Published
2021-07-09
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
10887709123585PackageGS1100In Commercial Distribution
00887709123588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770912358510887709123585
00887709123588008877091235888877091235880887709123588

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
10887709197272BivonaFT26FN70NSZ233N2026-07-23
10887709198392BivonaSU26GN80NZC083N2026-07-23
10887709198408BivonaZA26GN85NSC085N2026-07-23
10887709198750BivonaSZ26GN70ZSZ114N2026-07-23
10887709198873BivonaZU26GN75NSC099N2026-07-23
10887709198941BivonaZU26GN60NGF143N2026-07-23
10887709198958BivonaZU26GN55NGF144N2026-07-23
10887709199085BivonaFU26GN35NGF169N2026-07-23
10887709199092BivonaFT26GN35NGA089N2026-07-23
10887709199108BivonaFT26GN35NGE166N2026-07-23
10887709199115BivonaST26GN40NGF165N2026-07-23
10887709199146BivonaFT26GN55NGC172N2026-07-23
10887709199153BivonaFU26GN55NGC170N2026-07-23
10887709199160BivonaFT26GN50NGC171N2026-07-23
10887709199177BivonaFU26GN40NGA178N2026-07-23
10887709199184BivonaFU26GN55NSF173N2026-07-23
10887709199207BivonaST26GN50NSC177N2026-07-23
10887709199214BivonaFT26GN30NGF174N2026-07-23
10887709199221BivonaST26GN55NSC176N2026-07-23
10887709199238BivonaFT26GN40NGE175N2026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887709123595ICU MedicalICU MEDICAL, INC.PEH2024-01-18
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