FDA UDI
In Commercial Distribution
🇺🇸 United States
ULTRAFLO-V
DI: 00857182006203
·
Model: 607
·
Innovative Medical Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
48
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Basic Information
- Brand Name
- ULTRAFLO-V
- Primary DI
- 00857182006203
- Version / Model
- 607
- Catalog Number
- 607
- Company Name
- Innovative Medical Technologies, Inc.
- Labeler DUNS
- 792740578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 48
- Record Status
- Published
- Publish Date
- 2025-02-13
- Public Version
- 2
- Public Version Date
- 2025-05-15
- Public Version Status
- Update
- Public Device Record Key
- d6a07e4e-ede8-4163-af23-9a7cab95d399
Device Description
SAFETY BLOOD COLLECTION NEEDLE 21GX1.25"
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 |
|---|---|---|---|---|
| 58284 | Blood collection tube holder/needle | A sterile, hand-held cylindrical device with a pre-attached needle 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 with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00857182006197 | GS1 | ||||
| Primary | 00857182006203 | GS1 |
Customer Contacts
- Phone
- 8665201820
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172763 | 000 |