CIV-Flex™ Transducer Cover 610-1600

GUDID 00841436121354

Sterile (3.8 tapered to 1.7 x 122cm) TEE cover on an applicator

CIVCO MEDICAL INSTRUMENTS CO., INC.

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Primary Device ID00841436121354
NIH Device Record Key43d4feef-c585-447c-957d-e9bc49aa13fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCIV-Flex™ Transducer Cover
Version Model Number610-1600
Catalog Number610-1600
Company DUNS134614411
Company NameCIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436121354 [Package]
Contains: 10841436121351
Package: [12 Units]
In Commercial Distribution
GS110841436121351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

[00841436121354]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-17
Device Publish Date2022-02-09

On-Brand Devices [CIV-Flex™ Transducer Cover]

00841436104333Non-sterile (14 x 30cm) cover
00841436103695Non-sterile (14 x 61cm) cover
00841436103145Non-sterile (17.8 x 147cm) telescopically-folded cover
00841436101721Non-sterile (10.2 x 147cm) telescopically-folded cover
00841436101714Non-sterile (14 x 147cm) telescopically-folded cover
00841436101325Non-sterile (11.9 tapered to 3.8 x 61cm) flat-folded cover (no gel)
00841436102650Non-sterile (3.8 tapered to 1.7 x 122cm) TEE cover on applicator
00841436101622Sterile (3.8 tapered to 1.7 x 122cm) TEE cover on applicator
80841436104636CIV-Flex Transducer Cover (14 x 147cm) - Qty: 5. FUJIFILM SonoSite, Inc L25 Needle Guide (18GA)
00841436118248Sterile (10.1 tapered to 2.5 x 30.5cm) cover
00841436110167Sterile (8.9 x 30cm) CIV-Flex™ cover
00841436101639Non-sterile (3.8 tapered to 1.7 x 122cm) pediatric TEE cover on applicator, gel-filled syringe a
00841436101301Sterile (11.9 tapered to 3.8 x 61cm) flat-folded cover
00841436101295Sterile (22.9 x 61cm) flat-folded cover
00841436101288Sterile (17.8 x 61cm) flat-folded cover
00841436101271Sterile (14 x 61cm) flat-folded cover
00841436101264Sterile (8.9 x 61cm) flat-folded cover
0084143611990014 x 91.5cm telescopically-folded cover
00841436110389Sterile (14 x 147cm) telescopically-folded cover for use with BK Medical 6C2, 6C2s, 9C2, 8801, 8
00841436110334Sterile (8.9 x 91.5cm) telescopically-folded cover for use with BK Medical 6C2s, 9C2, 14L3, 8559
00841436110327Sterile (14 x 91.5cm) telescopically-folded cover for use with BK Medical 6C2, 10L2w, 13L4w, 880
00841436110228Sterile (8.9 x 61cm) cover for use with BK Medical 6C2, 6C2s, 9C2, 14L3, 18L5, 8670, 8802, 8814,
00841436110211Sterile (11.9 tapered to 3.8 x 61cm) flat-folded cover for use with BK Medical 8544, 8554, 8557,
00841436110204Sterile (14 x 61cm) cover for use with BK Medical 6C2, 10L2w, 13L4w, 8541, 8542, 8543, 8546, 854
10841436108604Sterile (14 x 30cm) cover, gel and bands
10841436108598Sterile (14 x 147cm) telescopically-folded cover, gel and bands
00841436104746Sterile (11.9 tapered to 3.8 x 91.5 cm) telescopically-folded cover
00841436104470Sterile (4.6 tapered to 2.5 x 122cm) TEE cover on applicator
00841436104289Non-sterile (4.6 tapered to 2.5 x 122cm) TEE cover on applicator
00841436104227Non-sterile (4.6 tapered to 2.5 x 122cm) TEE cover on applicator, gel-filled syringe and bite bl
00841436103923Sterile (8.9 x 91.5cm) telescopically-folded cover
00841436103763Sterile (14 x 147cm) telescopically-folded cover
00841436101905Sterile (14 x 91.5cm) telescopically-folded cover
00841436103671Sterile (6 x 91.5cm) flat-folded cover
00841436103114Sterile (7.4 tapered to 9.5 x 30.5cm) telescopically-folded transducer cover
00841436103107Sterile (14 x 147cm) telescopically-folded cover
00841436103084Sterile (14 x 30cm) cover
00841436102629Sterile (17.8 x 91.5cm) telescopically-folded cover
00841436102414Sterile (14 x 29.2cm) telescopically-folded wireless transducer cover
00841436102124Sterile (17.8 x 244cm) telescopically-folded cover
00841436102100Sterile (14 x 244cm) telescopically-folded cover
00841436102094Sterile (10.2 x 244cm) telescopically-folded cover
00841436101899Sterile (10.2 x 147cm) telescopically-folded cover
00841436101592Sterile (17.8 x 147cm) telescopically-folded cover
00841436101530Sterile (10.2 x 147cm) telescopically-folded cover
00841436114820Sterile (11.9 tapered to 3.8x244cm) telescopically folded cover
0084143611465314x244cm telescopically folded cover
00841436114639Sterile (10.1x244cm) telescopically folded cover with tapered end
0084143611441714x147cm telescopically folded cover
80841436118596Non-sterile (6x91.5cm) flat folded cover
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