K-Pack Embrace™ KNAS-2516RB
GUDID 55413206346115
K-Pack Embrace™ Active Safety Needle
Terumo Europe NV
Hypodermic needle, single-use| Primary Device ID | 55413206346115 |
| NIH Device Record Key | de4bd4db-6c96-40b1-b96a-b2f24f085460 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-Pack Embrace™ |
| Version Model Number | KNAS-2516RB |
| Catalog Number | KNAS-2516RB |
| 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 | true |
| 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 |
Customer Support Contacts
| 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 | |
| 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 | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com |
Device Dimensions
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 25 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| 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 |
| 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 |
| 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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05413206346110 [Primary] |
| GS1 | 55413206346115 [Package] Contains: 05413206346110 Package: Carton [1900 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K251447
FDA Product Code
| FMI | Needle, Hypodermic, Single Lumen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-23 |
| Device Publish Date | 2025-09-15 |
On-Brand Devices [K-Pack Embrace™]
| 55413206346122 | K-Pack Embrace™ Active Safety Needle |
| 55413206346115 | K-Pack Embrace™ Active Safety Needle |
Trademark Results [K-Pack Embrace]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 K-PACK EMBRACE 79350042 not registered Live/Pending |
Terumo Europe NV 2022-08-02 |
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