FDA UDI
In Commercial Distribution
🇺🇸 United States
SURSHIELD
DI: 34987350705625
·
Model: SR*SFF1832A
·
TERUMO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- SURSHIELD
- Primary DI
- 34987350705625
- Version / Model
- SR*SFF1832A
- Company Name
- TERUMO CORPORATION
- Labeler DUNS
- 690543319
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-04-26
- Public Version
- 1
- Public Version Date
- 2024-05-06
- Public Version Status
- New
- Public Device Record Key
- 1e99e7d9-ad32-464a-9c06-1e2cd6df0abe
Device Description
SURSHIELD-PUR 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 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 |
|---|---|---|---|---|
| FOZ | Catheter, intravascular, therapeutic, short-term less than 30 days | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64574 | Peripheral intravenous cannula | A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 54987350705629 | GS1 | Carton | 4 | In Commercial Distribution | |
| Primary | 34987350705625 | GS1 | ||||
| Unit of Use | 04987350705624 | GS1 |
Customer Contacts
- Phone
- +1(800)283-7866
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 0.95 | Millimeter | |
| Device Size Text, specify | Flow rate | ||
| Device Size Text, specify | Lumen volume of catheter | ||
| Length | 1.25 | Inch | |
| Outer Diameter | 1.3 | Millimeter | |
| Catheter Gauge | 18 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature and avoid excessive heat and humidity.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care.