Identity
- Trade Name
- HemoWeld Gun Handgun FDA UDI
- Generic Name
- Blood donor bag tube divider/sealer FDA UDI
- Device Name
- Portable sealer for blood bag tubes: HemoWeld Gun Handgun FDA UDI
- Model / Reference
- HWG2.01 FDA UDI
- Description
- Portable sealer for blood bag tubes: HemoWeld Gun Handgun FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033928530146 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
Yes
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
Category: Blood donor bag tube divider/sealer
HemoWeld Gun Handgun by Delcon Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood donor bag tube divider/sealer.
- Rapid Seal Tube Sealer SE340 — CENTRON CORPORATION · Class I
- Multisealer MS 500B — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Rapid Seal Tube Sealer SE470 — CENTRON CORPORATION · Class I
- Yingtai — Changsha Yingtai Instrument Co., Ltd · Class I
- Rapid Seal Tube Sealer SE530 — CENTRON CORPORATION · Class I
- MacoSeal SE160 — CENTRON CORPORATION · Class I
- Multi Sealer MS 1000 — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Rapid Seal Tube Sealer SE540 — CENTRON CORPORATION · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Delcon Srl
Sources (2)
- FDA UDI 7d879e16-68af-4cd2-a4f0-d5460469b7d5 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026