FDA.report

K-3oem EZ-ZONE

Primary DI
00817012027433
Brand
K-3oem EZ-ZONE
Company
KAP MEDICAL
Model
K-3oem-UK-B48-8
Catalog number
K-3oem-UK-B48-8
Device description
Pulsation, True Low Air Loss 8" High 48" 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
IOQBed, Flotation Therapy, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IOQBed, Flotation Therapy, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817012027433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817012027433008170120274338170120274330817012027433

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00817012031881K-0 ECO-ZONEK-0-CONV-X-MSK-0-CONV-X-MS2026-05-26
00817012031898K-0 ECO-ZONEK-0-RTC-CONV-X-MSK-0-RTC-CONV-X-MS2026-05-26
00817012031850K-6 TURN-ZONEU-K-6-MSU-K-6-MS2026-01-16
00817012031775K-6oem AIRE-TURN ASSIST K-6oem-X-MS-D-8K-6oem-X-MS-D-82025-09-26
00817012031782K-6oem AIRE-TURN ASSIST K-6oem-EU-X-MS-D-8K-6oem-EU-X-MS-D-82025-09-26
00817012031799K-6oem AIRE-TURN ASSIST K-6oem-UK-X-MS-D-8K-6oem-UK-X-MS-D-82025-09-26
00817012031744K-2oem ALT-AIRE+K-2oem-X-MS-D-8K-2oem-X-MS-D-82025-09-19
00817012031751K-2oem ALT-AIRE+K-2oem-EU-X-MS-D-8K-2oem-EU-X-MS-D-82025-09-19
00817012031768K-2oem ALT-AIRE+K-2oem-UK-X-MS-D-8K-2oem-UK-X-MS-D-82025-09-19
00817012031720K-4oem AIRE-FLOATMATRIX-ALALMS8X84MATRIX-ALALMS8X842025-09-05
00817012031737K-6 TURN-ZONEK-6-MS-84-DK-6-MS-84-D2025-09-04
00817012022179K-Z ZM ZMattQRCLRTB80SYSXMSQRCLRTB80SYSXMS2025-06-27
00817012031690K-4 D3XK-4-CMS-MS-8-DK-4-CMS-MS-8-D2025-06-13
00817012031706K-4 D3XK-4-CMS-B48-84-DK-4-CMS-B48-84-D2025-06-13
00817012031713K-4 D3XK-4-CMS-MS-84-8-DK-4-CMS-MS-84-8-D2025-06-13
00817012031683K-4 D3XK-4-NS-AVL-MS-NK-4-NS-AVL-MS-N2025-06-06
00817012031669K-3 AIRE-ZONEK-3-W2.0-BB-U-MSK-3-W2.0-BB-U-MS2025-04-04
00817012031676K-Zoem EZ-TURNK-Zoem-UK-AP-MSK-Zoem-UK-AP-MS2025-04-04
00817012031652K-2oemFAMSK-2oem-AU-CONV-X-MSK-2oem-AU-CONV-X-MS2025-01-10
00817012031621K-6 AIRE-TURN ASSISTK-6oemANK-6oemAN2024-11-22

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