Kolbs

GUDID 00816554010378

Gel-filled bed mattress overlay

Primary Device ID	00816554010378
NIH Device Record Key	5e003543-b3d6-4941-958c-49f14e46b640
Commercial Distribution Status	In Commercial Distribution
Brand Name	Kolbs
Version Model Number	KGELO
Company DUNS	800616612
Company Name	K2 Health Products LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00816554010378 [Primary]

IKY	MATTRESS, FLOTATION THERAPY, NON-POWERED

Steralize Prior To Use	false
Device Is Sterile	false

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