← Back to catalogue

Maxi-Gard

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
MAXI-GARD FDA UDI
Generic Name
Assistive jacket FDA UDI
Device Name
Maxi-Gard Jacket Sky Blue FDA UDI
Model / Reference
5702324 FDA UDI
Description
Maxi-Gard Jacket Sky Blue FDA UDI

Identifiers

Catalog Number
5702324 FDA UDI
Primary DI / UDI-DI
10304040139735 FDA UDI
FDA Product Code
LYU FDA UDI
GMDN Term
Assistive jacket FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4040 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Assistive jacket

Maxi-Gard by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assistive jacket.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI 03775d18-aff2-461c-8282-14a20eed6ff7 35 fields · synced May 30, 2026