Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Non-evacuated blood collection tube IVD, no additive FDA UDI
- Device Name
- Blood Collection Tube,Silicone Coated Tube, Glycerine Coated Red Stopper, No Additive, 2 mL Draw FDA UDI
- Model / Reference
- 8881301116 FDA UDI
- Description
- Blood Collection Tube,Silicone Coated Tube, Glycerine Coated Red Stopper, No Additive, 2 mL Draw FDA UDI
Identifiers
- Catalog Number
- 8881301116 FDA UDI
- Primary DI / UDI-DI
- 10884527002863 FDA UDI
- FDA Product Code
- GIM FDA UDI
- GMDN Term
- Non-evacuated blood collection tube IVD, no additive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 50 Millimeter FDA UDITotal Volume — 2 Milliliter FDA UDIOuter Diameter — 10.25 Millimeter FDA UDI
Monoject by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA UDI 909bc80b-8edc-4103-ad40-6fd1340aea2b 38 fields · synced Jun 1, 2026