NORM-JECT® NJ-4606755BMS

GUDID 04046955635832

10 ML NORM-JECT® LL BMS

B. Braun Melsungen Aktiengesellschaft

Metered-delivery hypodermic syringe

• Primary Device ID: 04046955635832
• NIH Device Record Key: 9beaea66-a335-47d8-baa4-204fb5cb8b33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NORM-JECT®
• Version Model Number: NJ-4606755BMS
• Catalog Number: NJ-4606755BMS
• Company DUNS: 315016972
• Company Name: B. Braun Melsungen Aktiengesellschaft
• Device Count: 90
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046955635825 [Primary]
GS1	04046955635832 [Package]; Contains: 04046955635825; Package: Carton [12 Units]; In Commercial Distribution
GS1	04046955636617 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063280

FDA Product Code

• FMF: Syringe, piston

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: 2025-07-22
• Device Publish Date: 2025-07-14

Devices Manufactured by B. Braun Melsungen Aktiengesellschaft

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• 04046955138043 - Omnican®: 2021-12-09 OMNICAN FINE 31G x 4MM GLUED W/O CAP US
• 04046964905063 - ACCEL®: 2019-11-06 2000ML EVACUATED DRAINAGE BOTTLE
• 04046955096763 - Subcutaneous Injection Supply Kit: 2019-10-23 The parenteral administration kit is composed to support the home application of a subcutaneous injection of fluids for medical
• 04046964613371 - ACCEL®: 2019-04-29 1000ML DRAINAGE BOTTLE, PVC-FREE