FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Omnican®
DI: 04046955064397
·
Model: 931G06S-02
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- Omnican®
- Primary DI
- 04046955064397
- Version / Model
- 931G06S-02
- Catalog Number
- 931G06S-02
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-09-22
- Public Version
- 5
- Public Version Date
- 2024-05-01
- Public Version Status
- Update
- Public Device Record Key
- 417db55a-9ba3-4472-9c0e-425c88dafe09
- Distribution End Date
- 2024-04-30
Device Description
OMNICAN FINE PEN NEEDLE 31GX6MM W CAP US
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
- No
- 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 |
|---|---|---|---|---|
| FMI | Needle, hypodermic, single lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44127 | Autoinjector needle | A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04046955064403 | GS1 | Carton | 10 | Not in Commercial Distribution | 2024-04-30 |
| Primary | 04046955064397 | GS1 | ||||
| Unit of Use | 04046955064380 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173803 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Outer- cannula : 0.250 MM | ||
| Device Size Text, specify | Length of cannula (inch) : 1/4" | ||
| Device Size Text, specify | Length of cannula (metric) : 6.000 MM | ||
| Device Size Text, specify | Gauge (cannula) : 31 |