FDA.reportPublic FDA data

Elbow Pillow Pad (Ripstop/Microsuede)

Primary DI
00810006683042
Brand
Elbow Pillow Pad (Ripstop/Microsuede)
Company
PRIMO INC
Model
EPP01
Catalog number
EPP01
Device description
Elbow Pillow Pad (Ripstop/Microsuede)
Published
2019-02-27
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

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
00810006683042PackageGS112In Commercial Distribution
00810006681642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810006683042008100066830428100066830420810006683042
00810006681642008100066816428100066816420810006681642

GMDN Terms#

Term, Definition table
TermDefinition
Arm/elbow protectorA device designed to be worn over the arm/elbow (various ranges from the base of the fingers to above the elbow) to provide a cover and/or cushion to protect the limb from friction and knocks against objects. It is typically made from soft padded materials and is held in place with bands or straps around the arm or can be elastic tubular in design so that it slides over the arm/elbow. It is typically used by persons that have tendencies for skin sores on their elbows/arms, are bedridden, or prone to lack of control with their arms causing injury. This is a reusable 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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