FDA UDI
Not in Commercial Distribution
🇺🇸 United States
one.click needle
DI: 04046963412791
·
Model: U1244101
·
EMD Serono, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- one.click needle
- Primary DI
- 04046963412791
- Version / Model
- U1244101
- Catalog Number
- 16440EMD
- Company Name
- EMD Serono, Inc.
- Labeler DUNS
- 088514898
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-08-26
- Public Version
- 4
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- 96c5eea0-07ac-4129-8a66-62de464e374c
- Distribution End Date
- 2023-10-02
Device Description
Needles for one.click® auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
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 |
|---|---|---|---|---|---|---|
| Primary | 04046963412791 | GS1 | ||||
| Unit of Use | 04046963412784 | GS1 | ||||
| Package | 04046963413804 | GS1 | 12 | Not in Commercial Distribution |
Customer Contacts
- Phone
- 1-800-582-7989
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 29 | Gauge |