FDA.reportPublic FDA data

Adult Lopez Valve®

Primary DI
10801741052368
Brand
Adult Lopez Valve®
Company
C. R. Bard, Inc.
Model
0056000
Catalog number
0056000
Device description
Adult Lopez Valve®
Published
2016-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10801741052368PackageGS150In Commercial Distribution
00801741052361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174105236810801741052368
00801741052361008017410523618017410523610801741052361

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding kit, adult/paediatric, sterileA collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
016898496
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741236563SURESTEPSSPEDINTS08SSPEDINTS082026-10-06
00801741236570SURESTEPSSPEDINTS10SSPEDINTS102026-10-06
00801741236587SURESTEPSSINTL15SSINTL152026-10-06
00801741236594SURESTEPSSINTL16CSSINTL16C2026-10-06
00801741236600SURESTEPSSINTS14SSINTS142026-10-06
00801741236617SURESTEPSSINTS14CSSINTS14C2026-10-06
00801741236624SURESTEPSSINTS16SSINTS162026-10-06
00801741236631SURESTEPSSINTS16CSSINTS16C2026-10-06
00801741045943Bard® DigniShield® Stool Management SystemSMS002SMS0022016-08-25
00801741050930Fecal Containment Device1900111900112020-09-22
00801741113147Bard® DigniShield® Stool Management System with ENFit™ENSMS002ENSMS0022016-11-03
00801741050817Leg Bag1505071505072020-09-23
00801741076039Catheter Stabilization DeviceVFDSPVFDSP2020-09-22
00801741076053Catheter Stabilization DeviceVFDSSPVFDSSP2020-09-22
00801741076077Catheter Stabilization DeviceFOL0100FOL01002020-09-22
00801741076091Catheter Stabilization DeviceFOL0101FOL01012020-09-22
00801741076114Catheter Stabilization DeviceFOL0102FOL01022020-09-22
00801741076145Catheter Stabilization DeviceFOL0105FOL01052020-09-22
00801741127625Bard® Leg Bag Holders1501111501112016-08-10
00801741127632Bard® Leg Bag Holders1501211501212016-08-10

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