Identity
- Trade Name
- Tempo FDA UDI
- Generic Name
- Antiseptic skin towelette FDA UDI
- Device Name
- Tempo Alcohol Prep Pads (Sterile) FDA UDI
- Model / Reference
- 8010 FDA UDI
- Description
- Tempo Alcohol Prep Pads (Sterile) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00891153001187 FDA UDI
- FDA Product Code
- LKB FDA UDI
- GMDN Term
- Antiseptic skin towelette FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Radiation Sterilization FDA UDI
Category: Antiseptic skin towelette
Tempo by Hemasource — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antiseptic skin towelette.
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- MedSource Antiseptic Towelettes — MEDSOURCE INTERNATIONAL LLC · 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 U | Pending data |
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Manufacturer
- Manufacturer
- Hemasource
Sources (1)
- FDA UDI aeefb825-6457-4734-9091-579d6d2a7603 33 fields · synced May 30, 2026