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Encompass

FDA UDI

Class I (US FDA UDI)

by Encompass Group, L.L.C.

Identity

Trade Name
Encompass FDA UDI
Generic Name
Patient gown, reusable FDA UDI
Device Name
GOWN IV PEDIATRIC SPACE ADVENT SIZE 9-12 KIDS IN SPACE ROYAL BLUE 100%P FDA UDI
Model / Reference
45752-912 FDA UDI
Description
GOWN IV PEDIATRIC SPACE ADVENT SIZE 9-12 KIDS IN SPACE ROYAL BLUE 100%P FDA UDI

Identifiers

Primary DI / UDI-DI
00609953995120 FDA UDI
FDA Product Code
FME FDA UDI
GMDN Term
Patient gown, 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Patient gown, reusable

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

Similar devices

Also classified as Patient gown, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Encompass Group, L.L.C.

Sources (1)

  • FDA UDI 33a89fb1-b692-4267-afe3-f71b3bdeb96d 34 fields · synced Jun 1, 2026