FDA UDI
In Commercial Distribution
🇺🇸 United States
TopRx 1st Tier UP
DI: 00761059540878
·
Model: AN 3540TRX
·
OWEN MUMFORD USA INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
Basic Information
- Brand Name
- TopRx 1st Tier UP
- Primary DI
- 00761059540878
- Version / Model
- AN 3540TRX
- Company Name
- OWEN MUMFORD USA INCORPORATED
- Labeler DUNS
- 803401454
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-06-02
- Public Version
- 1
- Public Version Date
- 2022-06-10
- Public Version Status
- New
- Public Device Record Key
- 097c866f-90e4-4535-855c-94dfbabd7eed
Device Description
TopRx 1st Tier UP Pentips - 4mmx32G
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00384703540002 | GS1 | ||||
| Primary | 00761059540878 | GS1 | ||||
| Package | 00761059541875 | GS1 | Sleeve | 10 | In Commercial Distribution | |
| Package | 00761059542872 | GS1 | Case | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 770-977-2226
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152339 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4 | Millimeter | |
| Needle Gauge | 32 | Gauge |