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Sign in to claim this brandPURELIFE, LLC
US
Last updated May 24, 2026
What PURELIFE, LLC makes
PureLife, LLC manufactures single-use medical barriers including nitrile and latex examination gloves, medical drapes, surgical dressing kits, and sterilization liners and packaging. Their portfolio also includes dental-specific items such as suction cannulas, bibs, and medicine cups designed for oral healthcare procedures.
The company’s products are regulated under FDA’s Class I and Class II device classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does PureLife, LLC manufacture?
PureLife, LLC specializes in single-use medical barriers and oral healthcare items. Their product line includes nitrile and latex examination gloves (non-powdered, non-antimicrobial), medical drapes, surgical dressing kits, sterilization liners and packaging, as well as dental-specific tools like suction cannulas, bibs, and medicine cups. These items are designed to protect patients and healthcare providers during medical and dental procedures.
Where is PureLife, LLC based, and what does that mean for its regulatory oversight?
PureLife, LLC is based in the United States, meaning its devices fall under FDA jurisdiction. The FDA classifies their products as either Class I or Class II, depending on risk level—Class I for low-risk items like some medical drapes and Class II for moderate-risk devices like dental suction systems. This classification determines the regulatory pathway for authorization.
Are PureLife, LLC’s devices listed in any regulatory registries, and why does that matter?
Yes, PureLife, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, helping healthcare providers verify product authenticity, recall history, and compliance status. Listing in the UDI system is a requirement for FDA-authorized devices to streamline tracking and reporting.
How are PureLife, LLC’s devices classified by the FDA, and what does that classification indicate?
PureLife, LLC’s devices are classified as either Class I or Class II by the FDA. Class I devices, like some medical drapes or sterilization liners, are generally low-risk and typically require general controls (e.g., good manufacturing practices) for authorization. Class II devices, such as dental suction cannulas or bibs, involve moderate risks and may require additional performance standards or post-market surveillance to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- purelifedental.com
- —
- —
- [email protected]
- Phone
- +1(877)777-3303
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 828690904
Catalogue (128)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PureOrtho | 1068501 | FDA UDI | Class I | Active |
| PureLife+ 2-Ply Dental Bibs | 1092002 | FDA UDI | Class I | Active |
| PureLife+ 5oz Plastic Cups | 1121003 | FDA UDI | Class I | Active |
| PureBliss | 1021703 | FDA UDI | Class I | Active |
| PureBerry | 1067101 | FDA UDI | Class I | Active |
| PureLife+ CSR Wrap | 1192103 | FDA UDI | Class II | Active |
| SuperNova | 1061204 | FDA UDI | Class I | Active |
| PureLife+ Sterilization Pouches | 1192004 | FDA UDI | Class II | Active |
| Azur | 1061704 | FDA UDI | Class I | Active |
| PureSkin | 1020104 | FDA UDI | Class I | Active |
| PureLife Dental | 1154901 | FDA UDI | Class II | Active |
| PureOnyx | 1068103 | FDA UDI | Class I | Active |
| PureBerry | 1067104 | FDA UDI | Class I | Active |
| PureOrtho | 1068503 | FDA UDI | Class I | Active |
| PureLife+ Surgical Aspirator Tips | 1147001 | FDA UDI | Class I | Active |
| Nova | 1060101 | FDA UDI | Class I | Active |
| PureLife+ CSR Wrap | 1192101 | FDA UDI | Class II | Active |
| PureLife Dental | 1110302 | FDA UDI | Class I | Active |
| PureLife Dental | 1150101 | FDA UDI | Class II | Active |
| Nova | 1060103 | FDA UDI | Class I | Active |
| PureLife+ Headrest Covers | 1084702 | FDA UDI | Class I | Active |
| PureLife+ Barrier Film | 1084502 | FDA UDI | Class I | Active |
| PureBliss | 1021701 | FDA UDI | Class I | Active |
| PureBliss | 1021705 | FDA UDI | Class I | Active |
| PureOrthoSense | 10684041068504 | FDA UDI | Class I | Active |
| PureSkin | 1020105 | FDA UDI | Class I | Active |
| PureLife+ Saliva Ejectors | 1147101 | FDA UDI | Class I | Active |
| PureLife Dental | 1190104 | FDA UDI | Class II | Active |
| PureLife Dental | 1150102 | FDA UDI | Class II | Active |
| PureLife+ High-Volume Evacuator Tips | 1147201 | FDA UDI | Class I | Active |
| PureLife+ 5oz Plastic Cups | 1121004 | FDA UDI | Class I | Active |
| PureGuard | 1024005 | FDA UDI | Class I | Unknown |
| PureGuard | 1024002 | FDA UDI | Class I | Unknown |
| PureLife+ 2-Ply Dental Bibs | 1092007 | FDA UDI | Class I | Active |
| PureBerry | 1067102 | FDA UDI | Class I | Active |
| PureLife+ Sterilization Pouches | 1192001 | FDA UDI | Class II | Active |
| PureOnyx | 1068102 | FDA UDI | Class I | Active |
| PureSkin | 1020102 | FDA UDI | Class I | Active |
| PureLife+ 2-Ply Dental Bibs | 1092006 | FDA UDI | Class I | Active |
| PureLife+ Surgical Aspirator Tips | 1147002 | FDA UDI | Class I | Active |
| Azur | 1061703 | FDA UDI | Class I | Active |
| PureLife+ Cotton Tip Applicators | 1113202 | FDA UDI | Class I | Active |
| PureGuard | 1024001 | FDA UDI | Class I | Unknown |
| PureLife Dental | 1190105 | FDA UDI | Class II | Active |
| Purelife | 1190106 | FDA UDI | Class II | Unknown |
| PureLife+ Tray Covers | 1084601 | FDA UDI | Class I | Active |
| PureLife+ Non-Woven Sponges | 1113002 | FDA UDI | Class I | Active |
| PureOnyx | 1068101 | FDA UDI | Class I | Active |
| Azur | 1061702 | FDA UDI | Class I | Active |
| PureLife+ Plastic Headrest Covers | 1084001 | FDA UDI | Class I | Active |
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