FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD Pen Needle 23G x 7mm
DI: 00382904736989
·
Model: 4736989
·
Becton, Dickinson and Company Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BD Pen Needle 23G x 7mm
- Primary DI
- 00382904736989
- Version / Model
- 4736989
- Catalog Number
- 47369802
- Company Name
- Becton, Dickinson and Company Inc
- Labeler DUNS
- 047047543
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-11
- Public Version
- 2
- Public Version Date
- 2022-06-08
- Public Version Status
- Update
- Public Device Record Key
- 7ae487d7-c4da-4c38-be24-d17cfbf11fc6
- Distribution End Date
- 2022-05-17
Device Description
23G ETW X 7MM PEN NEEDLE US
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
- 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 | 50382904736984 | GS1 | Case | 1800 | Not in Commercial Distribution | 2022-05-17 |
| Primary | 00382904736989 | GS1 |
Customer Contacts
- Phone
- +1(888)232-2737
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 23 | Gauge | |
| Length | 7 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius