MED-RX 54-7059

GUDID 50628725003868

FEEDING TUBE EXTENSION SET, ENTERAL ONLY, FOR PEDIATRIC USE

Canadian Hospital Specialties Limited

Nasogastric feeding tube

• Primary Device ID: 50628725003868
• NIH Device Record Key: 5c098355-3120-491d-9e6b-b17908a61d7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MED-RX
• Version Model Number: 54-7059
• Catalog Number: 54-7059
• Company DUNS: 240992693
• Company Name: Canadian Hospital Specialties Limited
• Device Count: 1
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM
• Phone: 905-825-9300
• Email: CHS@CHSLTD.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628725003863 [Primary]
GS1	50628725003868 [Package]; Contains: 00628725003863; Package: carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100700

FDA Product Code

• FPD: Tube, Feeding

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-06
• Device Publish Date: 2019-05-29

On-Brand Devices [MED-RX]

• 50628725005268: 30 ML ORAL SYRINGE
• 50628725005251: 20 ML ORAL SYRINGE
• 50628725005244: 10 ML ORAL SYRINGE
• 50628725005237: 5 ML ORAL SYRINGE
• 50628725005220: 3 ML ORAL SYRINGE
• 50628725005213: 1 ML ORAL SYRINGE
• 50628725005206: 60 ML ORAL SYRINGE
• 50628725005039: 60 ML ORAL/ENTERAL SYRINGE
• 50628725005022: 30 ML ORAL/ENTERAL SYRINGE
• 50628725005015: 20 ML ORAL/ENTERAL SYRINGE
• 50628725005008: 10 ML ORAL/ENTERAL SYRINGE
• 00628725004990: 5 ML ORAL/ENTERAL SYRINGE
• 50628725004988: 3 ML ORAL/ENTERAL SYRINGE
• 50628725004971: 1 ML ORAL/ENTERAL SYRINGE
• 00628725004617: FEEDING TUBE EXTENSION SET, ENTERAL ONLY, FOR PEDIATRIC USE
• 00628725003931: MED-RX I.V. ADMINISTRATION EXTENSION SET, 70" COILED SET WITH 'Y' TUBE
• 00628725003924: MED-RX I.V. ADMINISTRATION EXTENSION SET, 70" SET WITH 'Y'-TUBE & DUAL CHECK VALVE
• 00628725003887: FEEDING TUBE EXTENSION SET, ENTERAL ONLY, STANDARD BORE, FOR PEDIATRIC USE
• 00628725003870: FEEDING TUBE EXTENSION, ENTERAL ONLY, STANDARD BORE, FOR PEDIATRIC USE
• 00628725003856: 3 ML ORAL/ENTERAL SYRINGE
• 00628725003818: FEEDING TUBE ENTERAL ONLY EXTENSION SET, MICROBORE, PEDIATRIC USE
• 00628725003795: 60 ML ORAL/ENTERAL SYRINGE
• 00628725003788: 30 ML ORAL/ENTERAL SYRINGE
• 00628725003771: 20 ML ORAL/ENTERAL SYRINGE
• 00628725003764: 10 ML ORAL/ENTERAL SYRINGE
• 00628725003757: 5 ML ORAL/ENTERAL SYRINGE
• 00628725003740: 1 ML ORAL/ENTERAL SYRINGE
• 00628725003719: I.V. ADMINISTRATION EXTENSTION SET, COILED
• 00628725003702: MED-RX TRANSFER SET, SWABBABLE VALVE WITH VENTED SPIKE
• 00628725003696: MED-RX TRANSFER SET, SWABBABLE VALVE WITH UNIVERSAL SPIKE
• 00628725003344: MED-RX PATIENT DELIVERY SET, 86" 'Y'-TUBE, WITH DUAL CHECK VALVE
• 00628725003306: MED-RX PATIENT DELIVERY SET, 18", 'Y' TUBE WITH DUAL CHECK VALVE
• 00628725003283: MED-RX TRANSFER SET, 18" STANDARD BORE TUBING, SWABBABLE VALVE WITH VENTED SPIKE
• 00628725003030: MED-RX ENTERAL FEEDING TUBE, 8 FR X 36", POLYURETHANE, PEDIATRIC
• 00628725003023: MED-RX ENTERAL FEEDING TUBE, 8 FR X 24", POLYURETHANE, PEDIATRIC
• 00628725003016: MED-RX ENTERAL FEEDING TUBE, 8 FR X 16", POLYURETHANE, PEDIATRIC
• 00628725003009: MED-RX ENTERAL FEEDING TUBE, 6.5 FR X 36", POLYURETHANE, PEDIATRIC
• 00628725002996: MED-RX ENTERAL FEEDING TUBE, 6.5 FR X 24", POLYURETHANE, PEDIATRIC
• 00628725002989: MED-RX ENTERAL FEEDING TUBE, 6.5 FR X 16", POLYURETHANE, PEDIATRIC
• 00628725002972: MED-RX ENTERAL FEEDING TUBE, 5 FR X 36", POLYURETHANE, PEDIATRIC
• 00628725002965: MED-RX ENTERAL FEEDING TUBE, 5 FR X 24", POLYURETHANE, PEDIATRIC
• 00628725002958: MED-RX ENTERAL FEEDING TUBE, 5 FR X 16", POLYURETHANE, PEDIATRIC
• 00628725002941: ENTERAL FEEDING TUBE, POLYURETHANE, 4 FR, FOR PEDIATRIC USE
• 00628725002934: MED-RX ENTERAL FEEDING TUBE, 4 FR X 16", POLYURETHANE
• 00628725002927: FEEDING TUBE, ENTERAL ONLY, PEDIATRIC, 8 FR, PVC, RADIOPAQUE STRIPE
• 00628725002910: MED-RX ENTERAL FEEDING TUBE, 8 FR X 15", PVC
• 00628725002903: MED-RX ENTERAL FEEDING TUBE, 6 FR X 36", PVC
• 00628725002897: MED-RX ENTERAL FEEDING TUBE, 6FR X 15", PVC
• 00628725002880: MED-RX ENTERAL FEEDING TUBE, 5 FR X 36", PVC
• 00628725002873: MED-RX ENTERAL FEEDING TUBE, 5 FR X 15", PVC