FDA.report

K-2 SM SmartMatt

Primary DI
00817012027273
Brand
K-2 SM SmartMatt
Company
KAP MEDICAL
Model
K-2SM-UK-B42
Catalog number
K-2SM-UK-B42
Device description
Auto Immerssion, Alternating Pressure with On-Demand Low Air Loss 10" High 42" Wide Mattress, Bariatric UK System
Published
2020-06-25
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
false

Related Records

Contact Domains

Product Codes

CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817012027273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817012027273008170120272738170120272730817012027273

GMDN Terms

TermDefinition
Low-air-loss bedA mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a mattress made of a series of connected air inflated pillows upon which the patient lies, a compressor with a feed system, filters and a built-in control unit.

Sterilization Methods

Method

Contacts

PhoneEmail
951-340-4360sales@kapmedical.com

Regulatory Flags

DUNS number
135241342
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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