FDA UDI
In Commercial Distribution
🇺🇸 United States
MacoSeal SE160
DI: 08809241443520
·
Model: SE160
·
CENTRON CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MacoSeal SE160
- Primary DI
- 08809241443520
- Version / Model
- SE160
- Catalog Number
- SE160
- 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
- 3
- Public Version Date
- 2022-06-21
- Public Version Status
- Update
- Public Device Record Key
- 9018d160-34d8-40b2-a20d-4c26a2f1a08b
Device Description
The MacoSeal SE160 is a specially designed tube sealer for dual purpose use. The device can work as a stand-alone tube sealer and also can be easily configured as a multi-head sealing unit. The devices can be linked in series as many number of devices as users want at spacing between 70 to 95 mm.
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 | 08809241443520 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 4.4 | Kilogram | |
| Length | 6.9 | Centimeter | |
| Height | 24.5 | Centimeter | |
| Depth | 35. | Centimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity