FDA UDI
In Commercial Distribution
🇺🇸 United States
UltraFlo-C
DI: 00857182006784
·
Model: 681005
·
Innovative Medical Technologies, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- UltraFlo-C
- Primary DI
- 00857182006784
- Version / Model
- 681005
- Company Name
- Innovative Medical Technologies, Inc.
- Labeler DUNS
- 792740578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-30
- Public Version
- 1
- Public Version Date
- 2026-01-07
- Public Version Status
- New
- Public Device Record Key
- 6afd54f6-f6d1-4b50-852f-ff878c451566
Device Description
UltraFlo-C Capillary Collector EDTA-K2 100uL 50/bg
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GIO | Tube, Collection, Capillary Blood | Hematology | 864.6150 | 1 |
| NNI | Container, Specimen, Non-Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65289 | Biological fluid specimen capillary collector IVD | A sampling receptacle in the form of small plastic tube with a thin pointed tip intended to be used to collect any type of biological fluid specimen (e.g., tears, saliva, sweat, urine) from a patient’s body via capillary action. It is designed to be placed on the target fluid whereby the fluid is drawn into the vessel for its collection, containment, preservation and/or transportation for subsequent culture, analysis, and/or other investigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857182006784 | GS1 |
Customer Contacts
- Phone
- 9135150917
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius