| Primary Device ID | 55413206051033 |
| NIH Device Record Key | 6c2a91e0-42b2-487b-bc4b-19b6e43caef4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-Pack II |
| Version Model Number | KN-2713RBKT |
| Catalog Number | KN-2713RBKT |
| Company DUNS | 370193559 |
| Company Name | Terumo Europe NV |
| 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 |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 27 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05413206051038 [Primary] |
| GS1 | 55413206051033 [Package] Contains: 05413206051038 Package: Carton [5000 Units] In Commercial Distribution |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-09-05 |
| 55413206223683 | K-Pack II Needle |
| 55413206223645 | K-Pack II Needle |
| 55413206216739 | K-Pack II Needle |
| 55413206216722 | K-Pack II Needle |
| 55413206211956 | K-Pack II Needle |
| 05413206211418 | K-Pack II Needle |
| 55413206211130 | K-Pack II Needle |
| 05413206211050 | K-Pack II Needle |
| 55413206203647 | K-Pack II Needle |
| 55413206203555 | K-Pack II Needle |
| 55413206203548 | K-Pack II Needle |
| 55413206054553 | K-Pack II Needle |
| 55413206052672 | K-Pack II Needle |
| 55413206051040 | K-Pack II Needle |
| 55413206051033 | K-Pack II Needle |
| 55413206042314 | K-Pack II Needle |
| 55413206037082 | K-Pack II Needle |
| 05413206034338 | K-Pack II Needle |
| 55413206034326 | K-Pack II Needle |
| 55413206033206 | K-Pack II Needle |
| 55413206032667 | K-Pack II Needle |
| 55413206032650 | K-Pack II Needle |
| 55413206032643 | K-Pack II Needle |
| 05413206032037 | K-Pack II Needle |
| 55413206031868 | K-Pack II Needle |
| 05413206031771 | K-Pack II Needle |
| 55413206031745 | K-Pack II Needle |
| 55413206031318 | K-Pack II Needle |
| 55413206031165 | K-Pack II Needle |
| 05413206025053 | K-Pack II Needle |
| 55413206020541 | K-Pack II Needle |
| 55413206018142 | K-Pack II Needle |
| 55413206003810 | K-Pack II Needle |
| 55413206003803 | K-Pack II Needle |
| 55413206003797 | K-Pack II Needle |
| 55413206003780 | K-Pack II Needle |
| 55413206219174 | K-Pack II Needle |
| 55413206219167 | K-Pack II Needle |
| 55413206219150 | K-Pack II Needle |
| 55413206219136 | K-Pack II Needle |
| 35413206248217 | K-Pack II Needle |
| 55413206256537 | K-Pack II Needle |