FDA UDI
In Commercial Distribution
🇺🇸 United States
MACOSEAL LIGHT
DI: 03567050073097
·
Model: 9MSLIGHT00
·
MACO PHARMA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MACOSEAL LIGHT
- Primary DI
- 03567050073097
- Version / Model
- 9MSLIGHT00
- Company Name
- MACO PHARMA
- Labeler DUNS
- 577149081
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-27
- Public Version
- 3
- Public Version Date
- 2025-03-13
- Public Version Status
- Update
- Public Device Record Key
- d1323242-8823-4737-8e69-3c2acdcabef5
Device Description
MacoSeal LIGHT is a cordless, automatic, and portable tube sealer, designed for sealing tubing of blood bags systems. This sealer can be used in both fixed and mobile collection sites, as well as in preparation sites, to hermetically seal PVC tubing in an automatic operation that ensures the reproducible quality, width and separation of sealings. It is composed of three (3) mobile parts sold together, not separately.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 | 03567050073097 | GS1 |