| Primary Device ID | 00817827021589 |
| NIH Device Record Key | 64f71fe3-8330-41dc-8127-08cd59cc97bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 03-220-94 |
| Catalog Number | 03-220-94 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817827021084 [Primary] |
| GS1 | 00817827021589 [Package] Contains: 00817827021787 Package: [4 Units] In Commercial Distribution |
| GS1 | 00817827021787 [Package] Contains: 00817827021084 Package: [24 Units] In Commercial Distribution |
| KSB | Set, Transfer (Blood/Plasma) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 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 |