N/A 03-960-62

GUDID 00817827022678

Neonatal/Pediatric Transfer Set 150µ filter and syringe adapters

CHARTER MEDICAL, LTD.

Blood transfusion set

• Primary Device ID: 00817827022678
• NIH Device Record Key: 060c49b5-2425-41b5-a8a0-3f7fb93754c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 03-960-62
• Catalog Number: 03-960-62
• Company DUNS: 029062325
• Company Name: CHARTER MEDICAL, LTD.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817827022173 [Primary]
GS1	00817827022678 [Package]; Contains: 00817827022173; Package: [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000685

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [N/A]

• 00817827025792: Plasma Pooling Set-1000mL Collection Bag w/(3) 400mL Aliquot Bags and Distal Needle Adapter
• 00817827025785: Pooling Harness Set 10 Lead Pooling Bag, 600mL Bag
• 00817827025778: 400mL Transfer Bag with 5-Lead Tubing Assembly
• 00817827025761: Pooling Harness Set 6 Lead Pooling Bag 400mL
• 00817827025754: 400mL Transfer Bag with 5 Lead Harness Set
• 00817827025747: Pooling harness Set 4 Lead Pooling Bag, 400mL
• 00817827025730: 300mL Triple Aliquot System
• 00817827025723: 400mL Triple Bag Aliquot System
• 00817827025716: Pooling Harness Set 4 Lead Harness Set with 400mL Bag
• 00817827025709: 3000mL Bag
• 00817827025693: 3000mL Transfer Bag with Peircing Pin
• 00817827025686: 2000mL Transfer Pack with Peircing Pin
• 00817827025679: 1000mL Transfer Pack with Peircing Pin
• 00817827025662: 600mL - Double Aliquot Pack with piercing pin
• 00817827025655: 600mL Transfer Pack with Piercing Pin
• 00817827025648: 400mL Transfer Bag With Piercing Pin
• 00817827025631: 150mL TRANSFER BAG WITH PIERCING PIN
• 00817827025624: Pooling Harness Set 6 Lead Pooling Bag, 3000mL
• 00817827025617: Transfer Pack - 150mL Quad (4) 150µ * Unsegmented Tubing
• 00817827025600: 150mL 2 Bag Aliquot Systen with piercing pin
• 00817827025594: 150 mL Quad Aliquot Bag System
• 00817827025587: 150mL Six Bag Aliquot System with piercing pin
• 00817827025570: 150mL Triple Aliquot Bag System with piercing pin
• 00817827025563: 150mL Eight Bag Aliquot System with piercing pin unsegmented tubing
• 00817827025556: 600mL Bag with Needle Adapter AUTOLOGOUS TRANSFER SETS
• 00817827025549: 600mL Bag with Piercing Pin AUTOLOGOUS TRANSFER SETS
• 00817827025532: Pooling Harness Set 10 Lead Harness Set
• 00817827025525: Pooling Harness Set 6 Lead Harness Set
• 00817827025518: 150mL Six Bag Aliquot System With Peircinh Pin and Needless Syringe Adapter
• 00817827024559: Neonatal/Pediatric Syringe Set 40µ Filter with 60cc Syringe
• 00817827024542: Neonatal/Pediatric Syringe Set 40µ Filter with 35cc Monoject® Syringe
• 00817827024535: Neonatal/Pediatric Syringe Set 40µ Filter with Syringe Adapter
• 00817827024528: Neonatal/Pediatric Syringe Set 40µ Filter with 60cc Syringe
• 00817827024511: Neonatal/Pediatric Syringe Set 40µ Filter with 30cc Sryinge
• 00817827022715: Neonatal/Pediatric Syringe Set 150µ Filter, 60cc Syringe, 150mL bag
• 00817827022708: Neonatal/Pediatric Syringe Set 150µ Filter, 60cc Syringe, 150mL bag
• 00817827022692: Neonatal/Pediatric Syringe Set 150µ Filter, 60cc Syringe, 150mL bag
• 00817827022685: Neonatal/Pediatric Syringe Set 150µ Filter, 30cc Syringe, 150 mL bag
• 00817827022678: Neonatal/Pediatric Transfer Set 150µ filter and syringe adapters
• 00817827022654: Neonatal/Pediatric Syringe Set 150µm filter and 60cc syringe. Not Manufactured with DEHP
• 00817827022647: Neonatal/Pediatric Syringe Set 150µm filter and 60cc syringe. Not Manufactured with DEHP
• 00817827022630: Neonatal/Pediatric Syringe Set 150µ filter and 60cc syringe
• 00817827022623: Neonatal/Pediatric Syringe Set 150µ filter and 35cc syringe; not manufactured with DEHP
• 00817827022616: Neonatal/Pediatric Syringe Set 150µ and 35cc syringe
• 00817827022609: Neonatal/Pediatric Syringe Set 150µ filter and port adapter
• 00817827022593: Neonatal/Pediatric Syringe Set: 150µ filter and Syringe Adapter; not manufactured with DEHP
• 00817827022586: Neonatal/Pediatric Transfer Set 150µ filter and syringe adapter
• 00817827022579: Neonatal/Pediatric Syringe Set 150µ filter and syringe adapter
• 00817827022562: Neonatal/Pediatric Syringe Set 150µ and 60cc syringe
• 00817827022555: Neonatal/Pediatric Syringe Set: 150µ filter and 60cc syringe. Not Manufactured with DEHP