Enteral Feeding

GUDID 00020451101262

INTOPO Convert to Oral Syringe, Bulk, Non-Sterile

Medela LLC

Enteral feeding/medication connector, non-sterile

• Primary Device ID: 00020451101262
• NIH Device Record Key: 7a64647a-17eb-40bc-b32f-074e46f8a00e
• Commercial Distribution Discontinuation: 2018-08-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Enteral Feeding
• Version Model Number: 7772
• Company DUNS: 052002029
• Company Name: Medela LLC
• Device Count: 500
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020451101262 [Primary]
GS1	10020451101269 [Package]; Package: [1 Units]; Discontinued: 2018-08-14; Not in Commercial Distribution
GS1	40020451101260 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894206

FDA Product Code

• FMF: Syringe, Piston

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-09-30
• Device Publish Date: 2016-09-22

On-Brand Devices [Enteral Feeding]

• 20020451331564: Bifurcated Enteral Extension Set, 70", Low Volume Minibore, Approx. Priming Vol. 1.90 mL, TwistL
• 20020451331557: Enteral Extension Set, 70", Low Volume Minibore, Approx. Priming Vol. 1.50 mL, TwistLok
• 20020451331540: Bifurcated Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.70 mL, TwistL
• 10020451331536: Enteral Extension Set, 3", Small Kink Resistant, Approx. Priming Vol. 0.40 mL, TwistLok, Bulk, N
• 20020451331526: Enteral Extension Set, 2.5" Low Volume Minibore, Approx. Priming Vol. 0.50 mL, TwistLok
• 20020451331519: Enteral Extension Set, 12", Standard Bore, Approx. Priming Vol. 1.60 mL, TwistLok
• 20020451331502: Enteral Extension Set, 12", Small Kink Resistant, Approx. Priming Vol. 1.20 mL, TwistLok
• 20020451331496: Enteral Straw, 5", Standard Bore, Approx. Priming Vol. 0.40 mL, TwistLok
• 20020451331373: INTOPO Cap
• 20020451331298: PVC Enteral Feeding Tube, 42", 8FR, Approx. Priming Vol. 2.40 mL, TwistLok
• 20020451331281: PVC Enteral Feeding Tube, 36", 6.5FR, Approx. Priming Vol. 1.20 mL, TwistLok
• 20020451331274: PVC Enteral Feeding Tube, 36", 5FR, Approx. Priming Vol. 0.90 mL, TwistLok
• 20020451331267: PVC Enteral Feeding Tube, 26", 8FR, Approx. Priming Vol. 1.40 mL, TwistLok
• 20020451331250: PVC Enteral Feeding Tube, 26", 6.5FR, Approx. Priming Vol. 1.00 mL, TwistLok
• 20020451331243: PVC Enteral Feeding Tube, 26", 5FR, Approx. Priming Vol. 0.45 mL, TwistLok
• 20020451331236: PVC Enteral Feeding Tube, 16", 8FR, Approx. Priming Vol. 1.00 mL, TwistLok
• 20020451331229: PVC Enteral Feeding Tube, 16", 6.5FR, Approx. Priming Vol. 0.60 mL, TwistLok
• 20020451331212: PVC Enteral Feeding Tube, 16", 5FR, Approx. Priming Vol. 0.20 mL, TwistLok
• 20020451331205: PVC Enteral Feeding Tube, 16", 5FR, Approx. Priming Vol. 0.30 mL, TwistLok
• 20020451331199: Polyurethane Enteral Feeding Tube, 42", 8FR, Approx. Priming Vol. 2.00 mL, TwistLok
• 20020451331182: Polyurethane Enteral Feeding Tube, 42", 10FR, Approx. Priming Vol. 3.00, TwistLok
• 20020451331175: Polyurethane Enteral Feeding Tube, 36", 6.5FR, Approx. Priming Vol. 1.10 mL, TwistLok
• 20020451331168: Polyurethane Enteral Feeding Tube, 36", 5FR, Approx. Priming Vol. 0.65 mL, TwistLok
• 20020451331151: Polyurethane Enteral Feeding Tube, 20", 8FR, Approx. Priming Vol. 1.00 mL, TwistLok
• 20020451331144: Polyurethane Enteral Feeding Tube, 20", 6.5FR, Approx. Priming Vol. 0.60 mL, TwistLok
• 20020451331137: Polyurethane Enteral Feeding Tube, 20", 5FR, Approx. Priming Vol. 0.35 mL, TwistLok
• 20020451331120: Polyurethane Enteral Feeding Tube, 20", 4FR, Approx. Priming Vol. 0.18 mL, TwistLok
• 20020451331113: Polyurethane Enteral Feeding Tube, 16", 8FR, Approx. Priming Vol. 0.80 mL, TwistLok
• 20020451331106: Polyurethane Enteral Feeding Tube, 16", 6.5FR, Approx. Priming Vol. 0.50 mL, TwistLok
• 20020451331090: Polyurethane Enteral Feeding Tube, 16", 5FR, Approx. Priming Vol. 0.30 mL, TwistLok
• 20020451331076: Bifurcated Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.70 mL, TwistL
• 20020451331069: Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.30 mL, TwistLok/Adapter
• 20020451331052: Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.20 mL, FLL/MLL
• 20020451331045: Bifurcated Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.70 mL, FLL/Ad
• 20020451331038: Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.30 mL, FLL/Adapter
• 20020451331014: Bifurcated Enteral Extension Set, 60", Minibore, Approx. Priming Vol. 2.20 mL, TwistLok
• 20020451331007: Enteral Extension Set, 60", Minibore, Approx. Priming Vol. 2.00 mL, TwistLok
• 20020451330994: Enteral Extension Set, 60", Low Volume Minibore, Approx. Priming Vol. 1.30 mL, TwistLok
• 20020451101679: PVC Enteral Feeding Tube, 42", 8FR, Approx. Priming Vol. 2.00 mL, ENFit, Low Dose
• 20020451101662: PVC Enteral Feeding Tube, 36", 6.5FR, Approx. Priming Vol. 1.10 mL, ENFit, Low Dose
• 20020451101655: PVC Enteral Feeding Tube, 36", 5FR, Approx. Priming Vol. 0.65 mL, ENFit, Low Dose
• 20020451101648: PVC Enteral Feeding Tube, 26", 8FR, Approx. Priming Vol. 1.30 mL, ENFit, Low Dose
• 20020451101631: PVC Enteral Feeding Tube, 26", 6.5FR, Approx. Priming Vol. 0.75 mL, ENFit, Low Dose
• 20020451101624: PVC Enteral Feeding Tube, 26", 5FR, Approx. Priming Vol. 0.50 mL, ENFit, Low Dose
• 20020451101617: PVC Enteral Feeding Tube, 16", 8FR, Approx. Priming Vol. 1.00 mL, ENFit, Low Dose
• 20020451101600: PVC Enteral Feeding Tube, 16", 6.5FR, Approx. Priming Vol. 0.50 mL, ENFit, Low Dose
• 20020451101594: PVC Enteral Feeding Tube, 16", 5FR, Approx. Priming Vol. 0.35 mL, ENFit, Low Dose
• 20020451101587: Polyurethane Enteral Feeding Tube, 42", 8FR, Approx. Priming Vol. 2.00 mL, ENFit, Low Dose
• 20020451101570: Polyurethane Enteral Feeding Tube, 42", 10FR, Approx. Priming Vol. 3.20 mL, ENFit, Low Dose
• 20020451101563: Polyurethane Enteral Feeding Tube, 36", 6.5FR, Approx. Priming Vol. 1.10 mL, ENFit, Low Dose