FDA.report

E.M Adams co, inc.

Primary DI
58100013404790
Brand
E.M Adams co, inc.
Company
E.M. ADAMS, INC.
Model
3073-1
Device description
HEEL & ELBOW PROTECTOR
Published
2019-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
58100013404790PackageGS148In Commercial Distribution
18100013404808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5810001340479058100013404790
1810001340480818100013404808

GMDN Terms

TermDefinition
Heel protectorA device that is designed to be worn over the foot to provide a cushion to protect the heel from friction against surfaces and knocks against objects; the toes will protrude and not be protected. It is typically made from soft padded materials and is held in place with bands or straps around the foot or the foot can be slid into it like a sock. It is typically used by persons that have tendencies for skin sores on their heels, are bedridden, or prone to lack of control with their legs causing injury to the heels. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(772)461-0532EMADAMS@EMADAMSCO.COM

Regulatory Flags

DUNS number
001403807
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50840200325580E.M. Adams Co Inc14-70809JK-12023-11-21
50840200325566E.M. Adams Co, Inc114-A3609-12023-11-17
50840200301072E.M. Adams Co Inc114-A11341-12023-10-31
10840200325551E.M. Adams Co Inc114-31613-12023-10-31
50840200325528E.M. Adams Co, Inc.14-3497-12023-10-20
50840200325443E.M. Adams co, inc.EP30405L-12023-06-20
50840200325313E.M. Adams Company14-3390-12022-08-18
50840200313525E.M. ADAMS CO, INC26-0615XL-12022-07-17
50840200313549E.M. ADAMS CO, INC26-0615XXL-12022-07-17
50840200313563E.M. ADAMS CO, INC26-0615XXXL-12022-07-17
50840200313587E.M. ADAMS CO, INC26-0615XXXXL-12022-07-17
50840200313624E.M. ADAMS CO, INC26-0644-12022-07-17
50840200313648E.M. ADAMS CO, INC26-0654-12022-07-17
50840200314744E.M. ADAMS CO, INCEP28-30205B-12022-07-17
50840200314768E.M. ADAMS CO, INCEP28-30205G-12022-07-17
50840200314782E.M. ADAMS CO, INCEP28-30205U-12022-07-17
50840200314805E.M. ADAMS CO, INCEP28-30206B-12022-07-17
50840200314843E.M. ADAMS CO, INCEP28-30206U-12022-07-17
50840200314867E.M. ADAMS CO, INCEP28-30207B-12022-07-17
50840200314881E.M. ADAMS CO, INCEP28-30207G-12022-07-17

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