| Primary Device ID | 00894743001734 | 
| NIH Device Record Key | 630950e6-9f12-4938-9821-dee1de400abd | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | CAREFINE | 
| Version Model Number | 1100015 | 
| Company DUNS | 130518376 | 
| Company Name | FACET TECHNOLOGIES, LLC | 
| Device Count | 90 | 
| 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 | false | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | true | 
| Needle Gauge | 29 Gauge | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00894743001734 [Primary] | 
| GS1 | 10894743001731 [Unit of Use] | 
| GS1 | 20894743001738 [Package] Package: Case [30 Units] In Commercial Distribution | 
| FMI | Needle, Hypodermic, Single Lumen | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2019-07-03 | 
| Device Publish Date | 2017-03-10 | 
| 00894743001819 | CareFine with Quintapoint Pen Needles - 4mm x 32G - Mail Order | 
| 00894743001802 | CareFine with Quintapoint Pen Needles - 5mm x 32G - Mail Order | 
| 00894743001796 | CareFine with Quintapoint Pen Needles - 8mm x 31G - Mail Order | 
| 00894743001789 | CareFine with Quintapoint Pen Needles - 4mm x 32G | 
| 00894743001772 | CareFine with Quintapoint Pen Needles - 5mm x 32G | 
| 00894743001765 | CareFine with Quintapoint Pen Needles - 8mm x 31G | 
| 00894743001758 | CareFine Pen Needles - 8mm x 30G (3 bevel) - Mail Order | 
| 00894743001741 | CareFine Pen Needles - 6mm x 31G (3 bevel) - Mail Order | 
| 00894743001734 | CareFine Pen Needles - 12.7mm x 29G (3 bevel) - Mail Order | 
| 00894743001727 | CareFine Pen Needles - 8mm x 30G (3 bevel) | 
| 00894743001710 | CareFine Pen Needles - 6mm x 31G (3 bevel) | 
| 00894743001703 | CareFine Pen Needles - 12.7mm x 29G (3 bevel) | 
| 00894743001147 | CareFine with Quintapoint Pen Needles - 6mm x 32G - Mail Order | 
| 00894743001000 | CareFine with Quintapoint Pen Needles - 6mm x 32G | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CAREFINE  87131290  not registered Live/Pending | MEDIBIO USA, LLC 2016-08-08 | 
|  CAREFINE  85961695  4660443 Live/Registered | FACET TECHNOLOGIES, LLC 2013-06-17 |