FDA.report

Halyard

Primary DI
20885632373333
Brand
Halyard
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
48743
Device description
FOAM POSITIONER OR TABLE POSITIONING KITS TRENDELENBURG PAD POLYURETHANE FOAM BLUE INCLUDES EXTRA LARGE TRENDELENBURG PAD X1 CHEST PAD X1 BODY STRAP X1 HEAD POSITIONER X1 PAIR OF TRENDELENBURG ARM PROTECTORS X1 DISPOSABLE NOT MADE WITH NATURAL RUBBER LATEX HALYARD
Published
2022-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CCXSUPPORT, PATIENT POSITION

Product Code Classifications

CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20885632373333PackageGS16In Commercial Distribution
10885632373336PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007941230
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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10885632514678SurgiTrackSM45003071062026-03-02
10885632514401SurgiTrackSM450120A9822026-03-01
10885632514418SurgiTrackSM45012087AC2026-03-01

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