FDA.report

DERMACARE

Primary DI
30603354500717
Brand
DERMACARE
Company
EHOB INC
Model
REV00
Catalog number
DC302003010
Device description
32X73X2 SINGLE W/.375 CONV PAD
Published
2020-08-21
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
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30603354500717PackageGS112In Commercial Distribution
10603354500065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3060335450071730603354500717
1060335450006510603354500065

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
150600252
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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30603354600677TruVueREV00TRU0170A12025-03-20
10603354600680TruVueREV00TRU0170B12025-03-20
10603354600703TruVueREV00TRU0170HAA12025-03-20
30603354120670ComfortTopREV00PPCMFTOP2025-01-22
30603354201652WAFFLEREV002180WCHA0102024-12-18
30603354201676WAFFLEREV002200WCHA0102024-12-18
30603354201690WAFFLEREV002300WCHA0102024-12-18
10603354201702WAFFLEREV002400WCHA0102024-12-18
30603354201737WAFFLEREV002000WCHA0102024-12-18
30603354300706WAFFLEREV005450CXHA0102024-12-18
30603354130198BAMREV00B0155A12024-09-12
10603354130224BAMREV00B0155B12024-09-12
30603354130235BAMREV00B0155C12024-09-12
30603354130259BAMREV00B0165A12024-09-12
30603354130273BAMREV00B0165B12024-09-12
30603354130297BAMREV00B0165C12024-09-12
30603354130310BAMREV00B0166A12024-09-03
30603354130334BAMREV00B0166B12024-09-03
30603354130358BAMREV00B0166C12024-09-03
10603354130439BAMREV00Z0156A12024-09-03

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