Terumo NF-3013RBKE05M
GUDID 35413206251224
Injection Filter Needle
Terumo Europe NV
Hypodermic needle, single-use| Primary Device ID | 35413206251224 |
| NIH Device Record Key | 27c9e135-0d4a-4244-ad31-e8ce160a2e5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Terumo |
| Version Model Number | NF-3013RBKE05M |
| Catalog Number | NF-3013RBKE05M |
| 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
Device Dimensions
| Needle Gauge | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 | 30 Gauge |
| 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 |
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. |
| 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 | 05413206251223 [Primary] |
| GS1 | 35413206251224 [Package] Contains: 05413206251223 Package: Shelf box [100 Units] In Commercial Distribution |
| GS1 | 55413206251228 [Package] Package: Carton [30 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230951
FDA Product Code
| QYM | Ophthalmic Needle |
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 | 2023-11-06 |
| Device Publish Date | 2023-10-27 |
Devices Manufactured by Terumo Europe NV
| 55413206346115 - K-Pack Embrace™ | 2025-09-23 K-Pack Embrace™ Active Safety Needle |
| 55413206346122 - K-Pack Embrace™ | 2025-09-23 K-Pack Embrace™ Active Safety Needle |
| 35413206251224 - Terumo | 2023-11-06Injection Filter Needle |
| 35413206251224 - Terumo | 2023-11-06 Injection Filter Needle |
| 35413206222446 - Surguard®3 | 2022-11-07 Surguard®3 Safety Hypodermic Needle |
| 35413206222453 - Surguard®3 | 2022-11-07 Surguard®3 Safety Hypodermic Needle |
| 35413206222460 - Surguard®3 | 2022-11-07 Surguard®3 Safety Hypodermic Needle |
| 35413206222477 - Surguard®3 | 2022-11-07 Surguard®3 Safety Hypodermic Needle |
| 55413206256537 - K-Pack II | 2022-04-13 K-Pack II Needle |
Trademark Results [Terumo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TERUMO 98436800 not registered Live/Pending |
Terumo Kabushiki Kaisha 2024-03-06 |
 TERUMO 97802240 not registered Live/Pending |
Terumo Kabushiki Kaisha 2023-02-20 |
 TERUMO 86490751 5590542 Live/Registered |
Terumo Kabushiki Kaisha 2014-12-26 |
 TERUMO 73297771 1276674 Dead/Cancelled |
Terumo Kabushiki Kaisha (Termumo Corporation) 1981-02-19 |
 TERUMO 72322168 0890553 Dead/Cancelled |
KABUSHIKI KAISHA JINTAN TERUMO 1969-03-19 |
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