FDA UDI
In Commercial Distribution
🇺🇸 United States
SURSHIELD
DI: 36927675503924
·
Model: MN*SVS21B18
·
Terumo Medical Products (Hangzhou) Co., Ltd.
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
50
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- SURSHIELD
- Primary DI
- 36927675503924
- Version / Model
- MN*SVS21B18
- Catalog Number
- MN*SVS21B18
- Company Name
- Terumo Medical Products (Hangzhou) Co., Ltd.
- Labeler DUNS
- 544830912
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 4
- Public Version Date
- 2023-08-08
- Public Version Status
- Update
- Public Device Record Key
- 519115c2-1aab-4bbc-8470-3906c6729f06
Device Description
SURSHIELD Safety Winged Blood Collection Set
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 |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60579 | Luer-ended blood collection tube spike | A device intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from blood collection tubing or a needle to a blood specimen receptacle (e.g., evacuated blood collection tube, adapted syringe). It is designed to be fitted to a blood collection tube holder, where it connects to the tubing or needle via a Luer connection at one end, and penetrates an evacuated blood collection tube at the other end for blood collection. 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 |
|---|---|---|---|---|---|---|
| Package | 56927675503928 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 36927675503924 | GS1 | ||||
| Unit of Use | 06927675503923 | GS1 |
Customer Contacts
- Phone
- +1(800)283-7866
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 0.75 | Inch | |
| Needle Gauge | 21 | Gauge | |
| Device Size Text, specify | Type: Ultra-Thin Wall (UTW) | ||
| Device Size Text, specify | Tubing Length:7inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store at extreme temperature and humidity. Keep away from sunlight. Stacking limit by 5.Fragile, handle with care.Keep dry.