Speculum, Rectal 720400C1

GUDID B4247204000C1

Colonic lavage kit, non-surgical

Primary Device ID	B4247204000C1
NIH Device Record Key	d7365d49-9a38-4fc8-8a40-99262331c3bb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Speculum, Rectal
Version Model Number	SPO1 Large Bulb Speculum
Catalog Number	720400C1
Company DUNS	942667882
Company Name	CLEARWATER COLON HYDROTHERAPY, INC.
Device Count	1
DM Exempt	true
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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Phone	352-401-0303
Email	sales@colonhydrotherapy.com
Phone	352-401-0303
Email	sales@colonhydrotherapy.com

Length	6 Inch
Length	6 Inch

Special Storage Condition, Specify	Between 0 and 0 *Stored in Room Condition
Special Storage Condition, Specify	Between 0 and 0 *Stored in Room Condition

Device Issuing Agency	Device ID
HIBCC	B4247204000C1 [Package] Contains: B424720400C1 Package: Plastic Bag [1 Units] In Commercial Distribution
HIBCC	B424720400C1 [Primary]

FFQ	Speculum, Rectal

Steralize Prior To Use	false
Device Is Sterile	false

B4247204000C1	Speculum, Rectal Bulb Style Large ~ California Proposition 65 material Compliant, Phthalates &
B4247202000C1	Speculum, Rectal Bulb Style Small ~ California Proposition 65 material Compliant, Phthalates &
B4247201000C1	Speculum, Rectal Straight Style Small ~ California Proposition 65 material Compliant, Phthalat