Identity
- Trade Name
- H-Pette without Blade (1000 pieces) FDA UDI
- Generic Name
- Blood/blood culture specimen transfer spike IVD, manual FDA UDI
- Model / Reference
- 3611 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52536110 FDA UDI
- FDA Product Code
- GJG FDA UDI
- GMDN Term
- Blood/blood culture specimen transfer spike IVD, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.6160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood/blood culture specimen transfer spike IVD, manual
H-Pette without Blade (1000 pieces) by Helena Laboratories, Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood/blood culture specimen transfer spike IVD, manual.
- CultureSafe — Typenex Medical, LLC · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- H-Pette II (No Blade, Metal Canula) (1000 pieces) — Helena Laboratories, Corp. · Class I
- H-Pette Remover — Helena Laboratories, Corp. · Class I
- H-Pette with Blade (1000 pieces) — Helena Laboratories, Corp. · Class I
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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI d415740a-05f4-4ee1-a728-67952377e84b 33 fields · synced Jun 9, 2026