FDA UDI
In Commercial Distribution
🇺🇸 United States
DELTA-FLOW
DI: H6711002020
·
Model: T-Configuration
·
UTAH MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DELTA-FLOW
- Primary DI
- H6711002020
- Version / Model
- T-Configuration
- Catalog Number
- 100-202
- Company Name
- UTAH MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 094651270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2019-12-18
- Public Version Status
- Update
- Public Device Record Key
- 4820e776-8072-4771-be31-0cddb0b5901d
Device Description
CONTINUOUS FLUSH DEVICE, T-CONFIGURATION, 3CC/HR FLOW RATE
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 |
|---|---|---|---|---|
| KRA | Catheter, Continuous Flush | Cardiovascular | 870.1210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35511 | Vascular catheter flush valve, continuous | A specialized, sterile, Y-piece device intended to be connected in an infusion line to an indwelling catheter and provide for the connection of a second infusion source. The second source usually serves to maintain a low keep vein open (KVO) flow in the catheter to prevent clotting. This device (the flush valve) may be equipped with a manually-operated mechanism to permit flushing of the line at a free-flow rate. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H6711002021 | HIBCC | Box | 50 | In Commercial Distribution | |
| Primary | H6711002020 | HIBCC |
Customer Contacts
- Phone
- 800-533-4984
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K780479 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Flow Rate - 3 cc/hr |