FDA.reportPublic FDA data

Enteral Feeding

Primary DI
00020451101187
Brand
Enteral Feeding
Company
Medela LLC
Model
TL-CAP
Device description
Male TwistLok Non-Vented Cap, 10 units/package
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092986000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092986000ACACIA PISTON SYRINGEAcacia, Inc.2009-10-27FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20020451101181PackageGS150Not in Commercial Distribution
00020451101187PrimaryGS10
40020451101185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2002045110118120020451101181
00020451101187000204511011870204511011870020451101187
4002045110118540020451101185

GMDN Terms#

Term, Definition table
TermDefinition
Non-ISO80369-3-standardized oral syringe, single-useA manual device consisting of a calibrated hollow barrel (cylinder) and a moveable plunger intended for the administration of oral medication. The tip is not formatted according to the standard for small-bore connectors for enteral applications (ISO 80369-3) [i.e., not ENFit], however the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(888)633-3528cssupport@medela.com

Regulatory Flags#

DUNS number
052002029
Device count
10
Lot or batch
true
Expiration date on label
true

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
00020451332123Enteral FeedingTLCAP2018-02-22
00020451904160Pump In Style® Pro Bundle1010477182025-06-10
00020451904177Pump In Style® Pro Bundle1010477182025-06-10
00020451470931Pump In Style® Pro1010470932025-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593Polycarbonate syringe -DMC MEDICAL LIMITEDFMF2026-06-01
05391530753609Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01