FDA UDI
In Commercial Distribution
🇺🇸 United States
NIPRO BLOOD COLLECTION NEEDLE
DI: 10383790002452
·
Model: NM+22G38
·
NIPRO MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
Basic Information
- Brand Name
- NIPRO BLOOD COLLECTION NEEDLE
- Primary DI
- 10383790002452
- Version / Model
- NM+22G38
- Catalog Number
- NM+22G38-1M
- Company Name
- NIPRO MEDICAL CORPORATION
- Labeler DUNS
- 797372554
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- 4830f057-e4d8-408f-8907-884be30ac6fe
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
- 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 |
|---|---|---|---|---|
| 35209 | Non-fixed blood collection needle | A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40383790002453 | GS1 | 6 | In Commercial Distribution | ||
| Package | 20383790002459 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10383790002452 | GS1 | ||||
| Unit of Use | 00383790002455 | GS1 |
Customer Contacts
- Phone
- +1 (908) 393-7030
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Needle Length : 1. 1/2 inch | ||
| Needle Gauge | 22 | Gauge |