| Primary Device ID | 00850002860207 |
| NIH Device Record Key | 040d9099-2b4a-4211-927e-134ff0a50372 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comfort EZ |
| Version Model Number | i31556 |
| Catalog Number | 50002-0860-20 |
| Company DUNS | 116722847 |
| Company Name | S.D.I. USA, 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 | 31 Gauge |
| Needle Gauge | 31 Gauge |
| Needle Gauge | 31 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850002860207 [Primary] |
| GS1 | 20850002860201 [Unit of Use] |
| FMF | Syringe, Piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-01-25 |
| Device Publish Date | 2018-10-26 |
| 00850002860214 | Insulin Syringe - 100 count |
| 00850002860207 | Insulin Syringe - 100 count |
| 00850002860191 | Insulin Syringe - 100 count |
| 00850002860184 | Insulin Syringe - 100 count |
| 00850002860177 | Insulin Syringe - 100 count |
| 00850002860160 | Insulin Syringe - 100 count |
| 00850002860153 | Insulin Syringe - 100 count |
| 00850002860146 | Insulin Syringe - 100 count |
| 00850002860139 | Insulin Syringe - 100 count |
| 00850002860122 | Insulin Syringe - 100 count |
| 00850002860115 | Insulin Pen Needle |
| 00850002860108 | Insulin Pen Needle |
| 00850002860092 | Insulin Pen Needle |
| 00850002860085 | Insulin Pen Needle |
| 00850002860078 | Insulin Pen Needle |
| 00850002860061 | Insulin Pen Needle |
| 00850002860054 | Insulin Pen Needle |
| 00850002860047 | Insulin Pen Needle |
| 00850002860030 | Insulin Pen Needle |
| 00850002860023 | Insulin Pen Needle |