FDA UDI
In Commercial Distribution
🇺🇸 United States
Omnican® fine
DI: 04046955143191
·
Model: 931A04EUS
·
B. Braun Melsungen Aktiengesellschaft
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1500
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Basic Information
- Brand Name
- Omnican® fine
- Primary DI
- 04046955143191
- Version / Model
- 931A04EUS
- Catalog Number
- 931A04EUS
- Company Name
- B. Braun Melsungen Aktiengesellschaft
- Labeler DUNS
- 315016972
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1500
- Record Status
- Published
- Publish Date
- 2026-02-10
- Public Version
- 1
- Public Version Date
- 2026-02-18
- Public Version Status
- New
- Public Device Record Key
- 27900880-a334-4e11-a424-5d6f866f4030
Device Description
OMNICAN FINE 31G x 4MM GLUED W/O C. BULK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 04046955143184 | GS1 | ||||
| Primary | 04046955143191 | GS1 |
Customer Contacts
- Phone
- +1(888)822-7286
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173803 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Length of cannula (inch) : 5/32'' | ||
| Device Size Text, specify | Length of cannula (metric) : 4.000 MM | ||
| Device Size Text, specify | Outer- cannula : 0.250 MM | ||
| Device Size Text, specify | Gauge (cannula) : 31 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius