FDA UDI
In Commercial Distribution
🇺🇸 United States
Monoject
DI: 10884521013018
·
Model: 8881225190
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Monoject
- Primary DI
- 10884521013018
- Version / Model
- 8881225190
- Catalog Number
- 8881225190
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 9
- Public Version Date
- 2023-06-21
- Public Version Status
- Update
- Public Device Record Key
- 99fbea67-9d91-4bc2-8c0e-326e0fd76d6f
Device Description
Blood Collection/Infusion Set,Female Luer, 12 inch (30.5 cm) Tubing
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 |
|---|---|---|---|---|
| FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | General Hospital | 880.5200 | 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 | 20884521013015 | GS1 | CASE | 50 | In Commercial Distribution | |
| Primary | 10884521013018 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Needle Gauge,23,Gauge;Length,12 (tubing) and 3/4 (needle),Inch; |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- ;