FDA.reportPublic FDA data

ICU Medical

Primary DI
10887709098258
Brand
ICU Medical
Company
ICU MEDICAL, INC.
Model
M9000-SEFD
Catalog number
M9000-SEFD
Device description
ENFit™ Lopez Valve, Sterile
Published
2022-09-13
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
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
10887709098258PackageGS150In Commercial Distribution
00887709098251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770909825810887709098258
00887709098251008877090982518877090982510887709098251

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.

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
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