Primary Device ID | 04710810083198 |
NIH Device Record Key | b686b1c3-c85f-4a9c-96a9-da5cea5ee4f7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sil-Flex |
Version Model Number | 5181 |
Company DUNS | 527333326 |
Company Name | GaleMed Xiamen Co., Ltd. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
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 | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04710810083198 [Primary] |
GS1 | 24710810083192 [Package] Package: Box [2 Units] In Commercial Distribution |
GS1 | 44710810083196 [Package] Contains: 24710810083192 Package: Carton [12 Units] In Commercial Distribution |
BSJ | Mask, Gas, Anesthetic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2015-09-19 |
44710810083301 | Sil-Flex tube 10F/22F,14cm |
04710810083198 | New Sil-Flex Silicone Mask size 3, Child Large |