Primary Device ID | 50642621003944 |
NIH Device Record Key | b689da4b-2974-468c-8e40-766dce246d75 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BAXJECT II NTD |
Version Model Number | 1505834 |
Catalog Number | 1505834 |
Company DUNS | 079887619 |
Company Name | BAXALTA US INC. |
Device Count | 1 |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00642621003949 [Primary] |
GS1 | 20642621003943 [Package] Contains: 00642621003949 Package: Box [5 Units] In Commercial Distribution |
GS1 | 50642621003944 [Package] Contains: 20642621003943 Package: Case [20 Units] In Commercial Distribution |
LHI | Set, I.V. Fluid Transfer |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-28 |
50642621003944 - BAXJECT II NTD | 2018-07-06 |
50642621003944 - BAXJECT II NTD | 2018-07-06 |
50642621029234 - FlowEase [Subcutaneous] Infusion Set | 2018-07-06 |
50642621029241 - FlowEase [Subcutaneous] Infusion Set | 2018-07-06 |
50642621029258 - FlowEase [Subcutaneous] Infusion Set | 2018-07-06 |
00642621029383 - BAXJECT II Hi-Flow NTD | 2018-07-06 |