FDA.reportPublic FDA data

MEDLINE

Primary DI
00193489136589
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MSCBWEDGEMS
Catalog number
MSCBWEDGEMS
Device description
WEDGE COMPRESSED, MARTHA STEWART
Published
2024-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KICCUSHION, FLOTATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193489136586PackageGS14In Commercial Distribution
00193489136589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019348913658610193489136586
00193489136589001934891365891934891365890193489136589

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489069334NAMIC91400300914003002021-10-28
10193489069341NAMIC91400400914004002021-07-26
10193489077667NAMIC906324490190632449012022-02-23
10193489078039NAMICH74904490202H749044902022021-07-26
10193489111132MEDLINESTGWLR1865NTSTGWLR1865NT2021-07-18
10193489111149MEDLINESTGWLR3260NTSTGWLR3260NT2021-07-18
10193489111156MEDLINESTGWLR2135NTSTGWLR2135NT2021-07-18
10193489111163MEDLINESTGWLR2535JNTSTGWLR2535JNT2021-07-18
10193489111170MEDLINESTGWLR2535NTSTGWLR2535NT2021-07-18
10193489191653MEDLINEDYNDA2467DYNDA24672020-04-15
10193489196559MEDLINEMNS12330AMNS12330A2020-04-20
10653160343806MEDLINEMNS12330AMNS12330A2020-07-06
10653160346760MEDLINEECVC7165AECVC7165A2021-05-20
10653160366577MEDLINECVI5045CVI50452023-09-28
20193489087793Medline80045075800450752021-05-12
20653160349492MEDLINEGW1850IGW1850I2021-12-16
10193489006728MEDLINEURO12575URO125752026-10-23
10197344219261MEDLINEDYNDSCL1500RDYNDSCL1500R2026-10-23
10653160395461MEDLINEDYNDC3514BDYNDC3514B2026-10-24
10653160395713MEDLINEEBSI1586BEBSI1586B2026-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613732113247ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113254ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113261ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113278ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113285ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113292ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113308ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113315ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113322ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113339ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113346ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113353ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113360ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113377ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113384ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113391ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113407ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113414ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113421ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113438ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113445ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113452ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113469ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113476ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113483ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113490ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113506ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113513ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113520ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00089904011497Action®ACTION PRODUCTS, INC.KIC2026-09-22