Identity
- Trade Name
- PureLife+ Barrier Film FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- PureLife+ Barrier Film, Blue, 4"x 6" sheets, Available in clear or blue FDA UDI
- Model / Reference
- 1084502 FDA UDI
- Description
- PureLife+ Barrier Film, Blue, 4"x 6" sheets, Available in clear or blue FDA UDI
Identifiers
- Catalog Number
- 1084502 FDA UDI
- Primary DI / UDI-DI
- D79010845021 FDA UDI
- 510(k) Number
- K190484 FDA UDI
- FDA Product Code
- NRD FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical equipment/instrument drape, single-use
PureLife+ Barrier Film by Purelife, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190484 also covers:
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
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
- Purelife, Llc
Sources (1)
- FDA UDI d5765791-3a9e-400f-9eba-96ed2fd613d5 36 fields · synced May 30, 2026