Identity
- Trade Name
- MacoSeal SE160 FDA UDI
- Generic Name
- Blood donor bag tube divider/sealer FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SE160 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- SE160 FDA UDI
- Primary DI / UDI-DI
- 08809241443520 FDA UDI
- FDA Product Code
- KSD FDA UDI
- GMDN Term
- Blood donor bag tube divider/sealer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 4.4 Kilogram FDA UDILength — 6.9 Centimeter FDA UDIHeight — 24.5 Centimeter FDA UDIDepth — 35. Centimeter FDA UDI
Category: Blood donor bag tube divider/sealer
MacoSeal SE160 by Centron Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Centron Corporation
Sources (1)
- FDA UDI 9018d160-34d8-40b2-a20d-4c26a2f1a08b 36 fields · synced May 30, 2026