FDA UDI
In Commercial Distribution
🇺🇸 United States
HemoWeld Gun Handgun
DI: 08033928530146
·
Model: HWG2.01
·
DELCON SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- HemoWeld Gun Handgun
- Primary DI
- 08033928530146
- Version / Model
- HWG2.01
- Company Name
- DELCON SRL
- Labeler DUNS
- 440621212
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- 7d879e16-68af-4cd2-a4f0-d5460469b7d5
Device Description
Portable sealer for blood bag tubes: HemoWeld Gun Handgun
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 | 08033928530146 | GS1 |