PROcovers™ 610-075

GUDID 00841436101516

Sterile (2 x 20cm) latex cover

CIVCO MEDICAL INSTRUMENTS CO., INC.

Body-orifice ultrasound imaging transducer cover, basic, sterile

Primary Device ID	00841436101516
NIH Device Record Key	b1435af5-3478-4430-9be0-867b382d9f6c
Commercial Distribution Status	In Commercial Distribution
Brand Name	PROcovers™
Version Model Number	610-075
Catalog Number	610-075
Company DUNS	134614411
Company Name	CIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
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	true
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com

Device Dimensions

Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter
Length	20 Centimeter
Width	2 Centimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436101516 [Package] Contains: 10841436101513 Package: [24 Units] In Commercial Distribution
GS1	10841436101513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K970515

FDA Product Code

ITX	Transducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

[00841436101516]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2021-09-06
Device Publish Date	2017-08-22

On-Brand Devices [PROcovers™]

00841436110273	Non-sterile (2.6 x 30cm) cover for use with BK Medical 2050, 2052 and 20R3 transducers
00841436101677	Non-sterile (2.6 x 30cm) cover
00841436101448	Non-sterile (4 x 30cm) latex cover
00841436101431	Non-sterile (2.6 x 20cm) latex cover
00841436101424	Non-sterile (2 x 20cm) latex cover
00841436101455	Sterile (4 x 30cm) latex cover
00841436110181	Sterile (2.6 x 30cm) latex cover for use with BK Medical 2050, 2052, 20R3, 8544, 8554, 8558, 856
00841436103589	Sterile (2.6 x 30cm) latex cover
00841436103572	Sterile (2 x 30cm) latex cover
00841436101523	Sterile (2.6 x 20cm) cover
00841436101516	Sterile (2 x 20cm) latex cover