Primary Device ID | 00850002860061 |
NIH Device Record Key | fec1338d-5b21-4330-875d-121ba0d2c0af |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Comfort EZ |
Version Model Number | 32G5 |
Catalog Number | 50002-0860-06 |
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 | 32 Gauge |
Needle Gauge | 32 Gauge |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850002860061 [Primary] |
GS1 | 20850002860065 [Unit of Use] |
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 | 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 |