| Primary Device ID | 60889971118349 |
| NIH Device Record Key | 08b8f287-e6cc-4fb6-94b7-2af6849c6a5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HALF Blue X-ray Film WB |
| Version Model Number | HALF Blue X-ray Film WB |
| Catalog Number | 1118348 |
| Company DUNS | 793169512 |
| Company Name | CARESTREAM HEALTH, INC. |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 0 |
| Handling Environment Humidity | Between 60 Percent (%) Relative Humidity and 0 |
| Handling Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 0 |
| Handling Environment Humidity | Between 60 Percent (%) Relative Humidity and 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889971118347 [Unit of Use] |
| GS1 | 40889971118345 [Primary] |
| GS1 | 60889971118349 [Package] Contains: 40889971118345 Package: Case [5 Units] In Commercial Distribution |
| IWZ | Film, radiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-16 |
| 60889971623867 | 100SH 11X14IN HALF BLUE X-RAY |
| 60889971605382 | 100SH 18X43-7X17 HALF BLUE X-RAY |
| 60889971545749 | 100SH 24X30CM HALF BLUE X-RAY |
| 60889971246363 | 100SH 35X43-14X17 HALF BLUE X-RAY |
| 60889971205193 | 25SH 14X36IN HALF BLUE X-RAY |
| 60889971118349 | 100SH 10X12IN HALF BLUE X-RAY |
| 60889971088673 | 100SH 8X10IN HALF BLUE X-RAY |