| Primary Device ID | 00862850000094 |
| NIH Device Record Key | cd05a594-38ca-4b1c-94cc-98f26cb06c44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comfort EZ |
| Version Model Number | 33G 4mm |
| Catalog Number | 62850-0000-09 |
| Company DUNS | 004135503 |
| Company Name | SIMPLE DIAGNOSTICS INC |
| Device Count | 100 |
| 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 | false |
| OTC Over-The-Counter | true |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862850000094 [Primary] |
| GS1 | 20862850000098 [Unit of Use] |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2018-10-12 |
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| 00862850000230 | Insulin Syringe 31G .5cc 5/16" 100 count |
| 00862850000216 | Insulin Syringe 31G 1cc 5/16" 100 count |
| 00862850000209 | Insulin Syringe 30G .3cc 5/16" 100 count |
| 00862850000193 | Insulin Syringe 30G .5cc 5/16" 100 count |
| 00862850000186 | Insulin Syringe 30G 1cc 5/16" 100 count |
| 00862850000179 | Insulin Syringe 29G .5cc 1/2" 100 count |
| 00862850000162 | Insulin Syringe 29G 1cc 1/2" 100 count |
| 00862850000155 | Insulin Syringe 28G .5cc 1/2" 100 count |
| 00862850000148 | Insulin Syringe 28G 1cc 1/2" 100 count |
| 00862850000124 | Insulin Pen 29G 12mm length |
| 00862850000117 | Insulin Pen Needle 6mm length and 33 gauge |
| 00862850000100 | Insulin Pen Needle 5mm length and 33 gauge |
| 00862850000094 | Insulin Pen Needle 5/32 inch 4mm length and 33 gauge |
| 00862850000087 | Insulin Pen Needle 32G and 1/4 inch (6mm) length |
| 00862850000070 | Insulin Pen Needle 32G and 3/16 inch (5 mm) length |
| 00862850000063 | Insulin Pen 32G 5/32 inch (4 mm) length |
| 00862850000056 | Insulin Pen Needle 1/4 inch (6mm) length and 31 gauge |
| 00862850000049 | Insulin Pen Needle 31G and 3/16 inch (5 mm) length |
| 00862850000032 | Insulin Pen Needle 5/16 inch (8mm) length and 31 gauge |
| 00898302140902 | Insulin Syringe 30G .3cc 5/16" 100 count |
| 00898302140896 | Insulin Syringe 30G .5cc 5/16" 100 count |
| 00898302140889 | Insulin Syringe 30G 1cc 5/16" 100 count |
| 00898302140872 | Insulin Syringe 29G .5cc 1/2" 100 count |
| 00898302140865 | Insulin Syringe 29G 1cc 1/2" 100 count |
| 00898302140858 | Insulin Syringe 28G .5cc 1/2" 100 count |
| 00898302140841 | Insulin Syringe 28G 1cc 1/2" 100 count |
| 00898302140827 | Insulin Pen 29G 12mm length |
| 00898302140810 | Insulin Pen Needle 6mm length and 33 gauge |
| 00898302140803 | Insulin Pen Needle 5mm length and 33 gauge |
| 00898302140797 | Insulin Pen Needle 5/32 inch 4mm length and 33 gauge |
| 00898302140780 | Insulin Pen Needle 32G and 1/4 inch (6mm) length |
| 00898302140773 | Insulin Pen Needle 32G and 3/16 inch (5 mm) length |
| 00898302140766 | Insulin Pen 32G 5/32 inch (4 mm) length |
| 00898302140759 | Insulin Pen Needle 1/4 inch (6mm) length and 31 gauge |
| 00898302140742 | Insulin Pen Needle 31G and 3/16 inch (5 mm) length |
| 00898302140735 | Insulin Pen Needle 5/16 inch (8mm) length and 31 gauge |
| 00898302140643 | Insulin Syringe 31G .3cc 5/16" 100 count |
| 00898302140636 | Insulin Syringe 31G .5cc 5/16" 100 count |
| 00898302140612 | Insulin Syringe 31G 1cc 5/16" 100 count |