FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapid Seal Tube Sealer SE470
DI: 08809241442233
·
Model: SE470
·
CENTRON CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Rapid Seal Tube Sealer SE470
- Primary DI
- 08809241442233
- Version / Model
- SE470
- Catalog Number
- SE470
- Company Name
- CENTRON CORPORATION
- Labeler DUNS
- 557821760
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-03
- Public Version
- 2
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- 8e252f93-2fd4-4f46-870e-018e962e790f
Device Description
The Rapid Seal SE470 is a compact and lightweight tube sealer with a hand unit. The device is specially designed to seal the cord blood freezing bags and tubing. Long and slim sealing head is suitable for sealing the channels between two compartments of bag.
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
- Yes
- 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 | 08809241442233 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 10.6 | Centimeter | |
| Height | 15.0 | Centimeter | |
| Depth | 26.0 | Centimeter | |
| Weight | 3.5 | Kilogram |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius