FDA UDI
In Commercial Distribution
🇺🇸 United States
NORM-JECT®
DI: 04046955635825
·
Model: NJ-4606755BMS
·
B. Braun Melsungen Aktiengesellschaft
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
90
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Basic Information
- Brand Name
- NORM-JECT®
- Primary DI
- 04046955635825
- Version / Model
- NJ-4606755BMS
- Catalog Number
- NJ-4606755BMS
- Company Name
- B. Braun Melsungen Aktiengesellschaft
- Labeler DUNS
- 315016972
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 90
- Record Status
- Published
- Publish Date
- 2025-07-14
- Public Version
- 1
- Public Version Date
- 2025-07-22
- Public Version Status
- New
- Public Device Record Key
- 9beaea66-a335-47d8-baa4-204fb5cb8b33
Device Description
10 ML NORM-JECT® LL BMS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35904 | Metered-delivery hypodermic syringe | A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04046955635832 | GS1 | Carton | 12 | In Commercial Distribution | |
| Primary | 04046955635825 | GS1 | ||||
| Unit of Use | 04046955636617 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063280 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 10 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight