FDA UDI
In Commercial Distribution
🇺🇸 United States
Delta Fly®
DI: 08032248369023
·
Model: 3690222
·
DELTA MED SPA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Delta Fly®
- Primary DI
- 08032248369023
- Version / Model
- 3690222
- Company Name
- DELTA MED SPA
- Labeler DUNS
- 444776777
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2020-07-23
- Public Version Status
- Update
- Public Device Record Key
- b9add244-74a6-470c-9e73-8264f15c9e66
Device Description
Delta Fly Micro Bore F20 Winged Safety Needle
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
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58490 | Venous butterfly needle/set | An invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 58032248369028 | GS1 | Case | 20 | In Commercial Distribution | |
| Package | 38032248369024 | GS1 | Box | 60 | In Commercial Distribution | |
| Primary | 08032248369023 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140175 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 25 | Gauge | |
| Length | 20 | Millimeter | |
| Outer Diameter | 0.5 | Millimeter | |
| Pore Size | 20 | Micrometer |