FDA.reportPublic FDA data

Enteral Feeding

Primary DI
00020451101705
Brand
Enteral Feeding
Company
Medela LLC
Model
ENFDUALCAPCLD
Device description
Dual Cap, ENFit, Low Dose, Covidien
Published
2017-01-27
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
K894206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894206000INTOPOAcacia, Inc.1989-10-27FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20020451101709PackageGS150Not in Commercial Distribution
00020451101705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2002045110170920020451101709
00020451101705000204511017050204511017050020451101705

GMDN Terms#

Term, Definition table
TermDefinition
ENFit/non-ISO80369-standardized linear connectorA small, non-powered, noninvasive, tubular two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, ENLock, threaded or non-Luer-slip), intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection typically with tubing or syringe; it does not connect a vial/bottle (i.e., not a vial/bottle adaptor). It does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
052002029
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00020451906065Pump In Style Pro+ w/Harmony1010490552026-07-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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