FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Monoject
DI: 10884527006595
·
Model: 8881310448
·
Cardinal Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Monoject
- Primary DI
- 10884527006595
- Version / Model
- 8881310448
- Catalog Number
- 8881310448
- Company Name
- Cardinal Health, Inc.
- Labeler DUNS
- 080935429
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 10
- Public Version Date
- 2023-06-30
- Public Version Status
- Update
- Public Device Record Key
- 1adf99f3-dff0-46eb-aef6-1d5a44460cde
- Distribution End Date
- 2023-06-30
Device Description
Blood Collection Tube,Silicone Coated Lavender Stopper, EDTA (NA2) 7.5 mg, 5 mL Draw
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 |
|---|---|---|---|---|
| GIM | Tubes, vacuum sample, with anticoagulant | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37566 | Blood collection tube holder, single-use | A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884527006592 | GS1 | CASE | 1000 | Not in Commercial Distribution | 2023-06-30 |
| Primary | 10884527006595 | GS1 | ||||
| Unit of Use | 30884527006599 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 75 | Millimeter | |
| Total Volume | 5 | Milliliter | |
| Outer Diameter | 13 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry;Fragile;AVOID DIRECT SUNLIGHT