FDA UDI
In Commercial Distribution
🇺🇸 United States
ULTRAFLO-R
DI: 40857182006508
·
Model: 688
·
Innovative Medical Technologies, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- ULTRAFLO-R
- Primary DI
- 40857182006508
- Version / Model
- 688
- Catalog Number
- 688
- Company Name
- Innovative Medical Technologies, Inc.
- Labeler DUNS
- 792740578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2025-02-13
- Public Version
- 3
- Public Version Date
- 2026-04-02
- Public Version Status
- Update
- Public Device Record Key
- 3ea976ad-5b9b-4416-ad79-c05623de619a
Device Description
PUSH BUTTON SAFETY BLOOD COLLECTION SET 23GX3/4"X12" W HOLDER ATTACHED
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58497 | Blood collection set, invasive | A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device. | No | Active |
| 65416 | Basic intravenous administration set, invasive | A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. 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 | 00857182006517 | GS1 | ||||
| Primary | 40857182006508 | GS1 |
Customer Contacts
- Phone
- 8665201820
- [email protected]