Primary Device ID | 00812045031020 |
NIH Device Record Key | 96112e9a-0ca0-4d99-87bf-8c295ccd686d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FV-53 CHILD TWIN PEDO PAK |
Version Model Number | 18636 |
Company DUNS | 010016319 |
Company Name | Flow X Ray Corporation |
Device Count | 100 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00812045031020 [Primary] |
GS1 | 10812045031027 [Package] Package: [50 Units] In Commercial Distribution |
GS1 | 20812045031024 [Unit of Use] |
IWZ | Film, Radiographic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-17 |
Device Publish Date | 2023-08-09 |
00081204503900 - DV-58 ADULT ECONO PAK | 2023-08-17 D Speed, Size 2, 600 Single Film Packets. |
00812045030115 - DX-58 ADULT PAPER PAK | 2023-08-17 D Speed, Size 2, 150 Single Film Paper Packets. |
00812045030634 - DX-42 BITE CHEX | 2023-08-17 D Speed, Size 3, 100 Single Film Paper Packets |
00812045030832 - DV-57 ADULT TWIN VALUE PAK | 2023-08-17 D Speed, Size 2, 130 Double Film Packets. |
00812045030849 - DV-53 CHILD TWIN PEDO PAK | 2023-08-17 D Speed, Size 0, 100 Double Film Packets. |
00812045030856 - DSS-54 D CHILD SINGLE FILM BUTTERFLY PACKET | 2023-08-17 D Speed, Size 0, 75 Single Film Butterfly Barrier Packets |
00812045030863 - DSS-57 D ADULT SINGLE FILM BUTTERFLY PACKET | 2023-08-17 D Speed, Size 2, 100 Single Film Butterfly Barrier Packets. |
00812045030870 - DUPLICATING FILM, 14 X 17" | 2023-08-17 Duplicating Film, 14x17", 100 sheets per box. |