Enteral Feeding

Primary DI
20020451101440
Brand
Enteral Feeding
Company
MEDELA, INC.
Model
ENFMALELD
Device description
ENF-TL M/M Transitional Connector, Low Dose
Published
2016-09-22
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
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
20020451101440PackageGS150In Commercial Distribution
00020451101446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2002045110144020020451101440
00020451101446000204511014460204511014460020451101446

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(888)633-3528cssupport@medela.com
1-800-435-8316customer.sevice@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
2002045146457618mm PersonalFit™ Plus Breast shields1010464572024-05-21
10020451416240Solo™1010416242024-05-15
10020451467099Swing Maxi™ Hands-free1010467092024-05-14
20020451463623Pediatric Breast Pump Kit with Harmony1010463622024-05-08
20020451464477Breast Pump Kit with Harmony & 80mL container1010464472024-05-08
20020451101303ENFit Syringe 1mlENF01LD1010331592024-05-06
20020451100603Enteral FeedingENPU-16-402016-09-22
20020451331083Enteral FeedingENPU16402017-12-20
10020451101719Enteral FeedingENFDUALCAPCNSLD2017-01-27
20020451100894Enteral FeedingINT-CAP2016-09-22
20020451101181Enteral FeedingTL-CAP2016-09-22
10020451101467Enteral FeedingENFMEDCAPNSLD2016-09-22
20020451101709Enteral FeedingENFDUALCAPCLD2017-01-27
00020451463445Colostrum Protector1010463442023-11-01
20020451457837Hands-free Breast shields, 27mm1010457832023-10-30
20020451101402Enteral FeedingENFCAPLD2016-09-22
20020451101419Enteral FeedingENFDUALCAPLD2016-09-22
10020451101429Enteral FeedingENFDUALCAPNSLD2016-09-22
20020451101433Enteral FeedingENFFEMALELD2016-09-22
20020451101457Enteral FeedingENFMEDCAPLD2016-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
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05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
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05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
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05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
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05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
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05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
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