FDA.reportPublic FDA data

Enteral Feeding

Primary DI
20020451331564
Brand
Enteral Feeding
Company
Medela LLC
Model
TL07019
Device description
Bifurcated Enteral Extension Set, 70", Low Volume Minibore, Approx. Priming Vol. 1.90 mL, TwistLok
Published
2017-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895367000INTRAVENOUS EXTENSION SETMedical Product Specialists1989-10-06FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20020451331564PackageGS1100In Commercial Distribution
00020451331560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2002045133156420020451331564
00020451331560000204513315600204513315600020451331560

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
1-800-435-8316customer.service@medela.com

Regulatory Flags#

DUNS number
052002029
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
00020451904870Freestyle™ Mini Hands-free1010483952026-05-01
01220000280335Motion InBra™ Double Pumping set1010476012026-03-10
01220000280342Motion InBra™ Single Pumping set1010476022026-03-10
01220000280731Motion InBra™ Double Pumping set1010476012026-03-10
01220000280748Motion InBra™ Single Pumping set1010476022026-03-10
00020451903873Motion InBra™1010475542026-02-16
00020451903880Motion InBra™1010475552026-02-16
00020451904566Motion InBra™1010475542026-02-16
00020451904573Motion InBra™1010475552026-02-16
00020451470917Pump In Style® Pro+1010470912026-01-28
00020451470924Pump In Style® Pro+ Hands-free1010470922026-01-28
00020451473390Pump In Style® Pro+ Bundle1010473392026-01-28
10020451470914Pump In Style® Pro+1010470912026-01-28
10020451470921Pump In Style® Pro+ Hands-free1010470922026-01-28
10020451473397Pump In Style® Pro+ Bundle1010473392026-01-28
00020451100890Enteral FeedingINT-CAP2016-09-22
00020451101187Enteral FeedingTL-CAP2016-09-22
00020451332123Enteral FeedingTLCAP2018-02-22
00020451904160Pump In Style® Pro Bundle1010477182025-06-10
00020451904177Pump In Style® Pro Bundle1010477182025-06-10

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