| Primary Device ID | 10816340023121 |
| NIH Device Record Key | 0b0a8e75-59d5-44f0-a79e-30620ba94c34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CT KIT |
| Version Model Number | CT KIT |
| Company DUNS | 189670230 |
| Company Name | NEODEVICES 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816340023124 [Primary] |
| GS1 | 10816340023121 [Package] Contains: 00816340023124 Package: [5 Units] In Commercial Distribution |
| GBM | Catheter, Urethral |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-17 |
| Device Publish Date | 2023-02-09 |
| 00816339023159 - SS-1660 | 2025-04-07 Blood Transfusion Shuttle Set |
| 10816340023145 - Marian Medical | 2025-04-07 72” with a non-vented blood bag spike, a piece of tubing approximately 5”. Connected to a drip chamber with a 150µ filter, |
| 10816340028355 - NeoDevices, Inc. | 2025-03-21 60” Enteral Extension set with Purple Enteral Locking Connectors (ISO 80369-3 compatible) |
| 00816340023131 - SS-1660.13 | 2024-04-25 Blood Transfusion Shuttle Set |
| 10816340027921 - NeoDevices, Inc. | 2023-12-04 Neonatal LP Needle 22ga x 1" |
| 10816340027938 - NeoDevices, Inc. | 2023-12-04 Neonatal LP Needle 22ga x 1.5" |
| 10816340027808 - NeoDevices, Inc. | 2023-06-02 Blood filter 17 micron |
| 10816340023121 - CT KIT | 2023-02-17 |
| 10816340023121 - CT KIT | 2023-02-17 |