FDA UDI
In Commercial Distribution
🇺🇸 United States
Yingtai
DI: 06976301910505
·
Model: Iseal-320
·
Changsha Yingtai Instrument Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Yingtai
- Primary DI
- 06976301910505
- Version / Model
- Iseal-320
- Company Name
- Changsha Yingtai Instrument Co., Ltd
- Labeler DUNS
- 544727865
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-01
- Public Version
- 1
- Public Version Date
- 2025-03-10
- Public Version Status
- New
- Public Device Record Key
- b506174b-f69b-4f4f-9f9a-74363295cf1f
Device Description
Tube sealer is an industrial device that uses heat and pressure to securely seal materials such as plastic films, non-woven fabrics, or composite materials. It is widely used in fields such as food packaging, pharmaceutical product sealing, industrial manufacturing, and laboratory research. With its efficient operation and reliable sealing, it is an ideal choice for ensuring product integrity and extending storage life.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSD | Device, Heat-Sealing | Hematology | 864.9750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63858 | Blood donor bag tube divider/sealer | An electrically-powered device designed to use heat to segment the plastic input tube of a blood donor bag, with automatic sealing of the ends of the divided segments. It may be used to create two or more segments, using heat to make a seal, after which the tube can be transected (e.g., for cross-testing sampling). It is typically used in blood donation centres and blood banks and is available in a variety of forms (e.g., hand-held, desktop); some types have barcode reading and labelling capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06976301910505 | GS1 |