Encompass

FDA UDI

Class I (US FDA UDI)

by Encompass Group, L.L.C.

Identity

Trade Name: Encompass FDA UDI
Generic Name: Basic bed sheet, reusable FDA UDI
Device Name: SHEET FLAT 70X108 T180 MISTY O.R. SHEET T-180 MISTY GREEN 70X108 55C/45P BLEND FDA UDI
Model / Reference: 49414-455 FDA UDI
Description: SHEET FLAT 70X108 T180 MISTY O.R. SHEET T-180 MISTY GREEN 70X108 55C/45P BLEND FDA UDI

Identifiers

Primary DI / UDI-DI: 00609953667935 FDA UDI
FDA Product Code: FME FDA UDI
GMDN Term: Basic bed sheet, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6265 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Basic bed sheet, reusable

Encompass by Encompass Group, L.L.C. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Encompass Group, L.L.C.

Sources (1)

FDA UDI a79581f9-29bd-4412-8251-bdc16edaa867 34 fields · synced May 30, 2026