FDA.reportPublic FDA data

ICU Medical

Primary DI
00887709037120
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
M9000
Device description
Lopez Valve®, Non-Sterile
Published
2019-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K915171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915171000LOPEZ VALVE TM IIIcu Medical, Inc.1992-02-07KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709037127PackageGS150In Commercial Distribution
00887709037120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770903712710887709037127
00887709037120008877090371208877090371200887709037120

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
true
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
10887709207100BivonaXU26JS40NGE159N2026-10-22
10887709207117BivonaFU26JN60NSC161N2026-10-22
10887709207124BivonaFU26JN50NGC162N2026-10-22
10887709207131BivonaHU26JS70NSC158N2026-10-22
10887709207148BivonaFT26JN40NGF157N2026-10-22
10887709207155BivonaFT26JN35NGE140N2026-10-22
10887709207162BivonaFT26JN50NSF156N2026-10-22
10887709207179BivonaFT26JN65NSC160N2026-10-22
10887709207193BivonaFT26JN60NSC164N2026-10-22
10887709207209BivonaFT26JN35NGF165N2026-10-22
10887709207216BivonaAT26JS35NSA151N2026-10-22
10887709207223BivonaAT26JS40NSA150N2026-10-22
10887709207032BivonaFT26JN30NGE149N2026-10-21
10887709207049BivonaFT26JN35NGE148N2026-10-21
10887709207056BivonaFT26JN40NGE145N2026-10-21
10887709207063BivonaXU26JS50NSC147N2026-10-21
10887709207070BivonaFT26IN40NSF242N2026-10-21
10887709207087BivonaFU26JN60NGA155N2026-10-21
10887709207094BivonaFU26JN40NGF146N2026-10-21
10887709206905BivonaFU26JN40NSC136N2026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071146474MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071146481MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071146498MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071146504MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071146535MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071146542MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071147075MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071147082MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071147259MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00842071147266MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-22
00350770997780MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
00350770997797MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTWAvanos Medical, Inc.KNT2026-10-20
00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00842071146337MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146344MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146375MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146382MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146795MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071146801MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147136MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147143MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147150MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20
00842071147167MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-20