Micro-Suede Body Wedge - Standard

Primary DI
00810006682915
Brand
Micro-Suede Body Wedge - Standard
Company
PRIMO INC
Model
BPW03
Catalog number
BPW03
Device description
Micro-Suede Body Wedge - Standard (15” x 9” x 11”)
Published
2019-02-20
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

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810006682915PackageGS110In Commercial Distribution
00810006681482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810006682915008100066829158100066829150810006682915
00810006681482008100066814828100066814820810006681482

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
958758146
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810006680072Glide & Guide Turn Sheet GGS3660GGS36602019-02-27
00810006680089Glide & Guide Turn Sheet GGS3660TSGGS3660TS2019-02-27
00810006680096Glide & Guide Turn Sheet GGS5660GGS56602019-02-27
00810006680355Glide & Guide Turn Sheet Select GGS3660FGGS3660F2019-02-27
00810006680362Glide & Guide Turn Sheet Select GGS3660SSFGGS3660SSF2019-02-27
00810006680379Glide & Guide Turn Sheet GGS3660SSGGS3660SS2019-02-27
00810006680386Glide & Guide Turn Sheet Select GGS3660TSFGGS3660TSF2019-02-27
00810006680393Glide & Guide Turn Sheet GGS4460GGS44602019-02-27
00810006680409Glide & Guide Turn Sheet GGS4460SSGGS4460SS2019-02-27
00810006680416Glide & Guide Turn Sheet GGS4460TSGGS4460TS2019-02-27
00810006680423Glide & Guide Turn Sheet Select GGS5660FGGS5660F2019-02-27
00810006680430Glide & Guide Turn Sheet GGS5660SSGGS5660SS2019-02-27
00810006680447Glide & Guide Turn Sheet Select GGS5660SSFGGS5660SSF2019-02-27
00810006680454Glide & Guide Turn Sheet GGS5660TSGGS5660TS2019-02-27
00810006680461Glide & Guide Turn Sheet Select GGS5660TSFGGS5660TSF2019-02-27
00810006681574Glide & Guide Turn Sheet GGS3660PSGGS3660PS2019-02-27
00810006681598Glide & Guide Turn Sheet GGS5660PSGGS5660PS2019-02-27
00810006682366Synthetic Sheepskin Bed OverlaySS3024SS30242019-02-27
00810006682373Synthetic Sheepskin Bed OverlaySS3040SS30402019-02-27
00810006682380Synthetic Sheepskin Bed OverlaySS3060SS30602019-02-27

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