FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SURFLASH
DI: 34987350709883
·
Model: SR*FNP2225
·
TERUMO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- SURFLASH
- Primary DI
- 34987350709883
- Version / Model
- SR*FNP2225
- Company Name
- TERUMO CORPORATION
- Labeler DUNS
- 690543319
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 3
- Public Version Date
- 2018-09-14
- Public Version Status
- Update
- Public Device Record Key
- 7b36ff7a-b3ad-4138-8098-7e681aed462b
- Distribution End Date
- 2018-08-29
Device Description
SURFLASH safety I.V. catheter
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
- No
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40601 | Peripheral vascular catheter | A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 54987350709887 | GS1 | 4 | Not in Commercial Distribution | 2018-08-29 | |
| Primary | 34987350709883 | GS1 | ||||
| Unit of Use | 04987350709882 | GS1 |
Customer Contacts
- Phone
- +1(800)283-7866
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Catheter Gauge 22 Gauge | ||
| Length | 1 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Stacking limit by 5, Keep away from sunlight, Fragile, handle with care, Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store at extreme temperature and humidity.