Situate 01-0034

GUDID 10884521700659

Delivery Console 200LD-V

Covidien LP

Surgical sponge-counting rack Surgical sponge-counting rack Surgical sponge-counting rack Surgical sponge-counting rack Surgical sponge-counting rack Surgical sponge-counting rack Surgical sponge-counting rack Surgical sponge-counting rack Surgical sponge-counting rack Surgical sponge-counting rack Surgical sponge-counting rack Surgical sponge-counting rack Surgical sponge-counting rack
Primary Device ID10884521700659
NIH Device Record Key83bf8e3d-984b-4ad7-bc24-0c1e285880a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSituate
Version Model Number01-0034
Catalog Number01-0034
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 0.7 KiloPascal and 1.06 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521700659 [Primary]

FDA Product Code

LWHCounter, sponge, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-27
Device Publish Date2018-09-24

On-Brand Devices [Situate]

30884521722259Sterile Drape For use with Situate Room Scanner; Caution: For Manufacturing, Processing or Repac
20884521700779Gauze-RF and X-ray Detectable USP Type VII, 8 Ply. Caution: For Manufacturing, Processing or Rep
20884521709888OR Towel - RF and X-ray Detectable Green. Caution: For Manufacturing, Processing or Repacking.
20884521701066OR Towel -RF and X-ray Detectable White. Caution: For Manufacturing, Processing or Repacking.
20884521701059OR Towel -RF and X-ray Detectable Blue. Caution: For Manufacturing, Processing or Repacking.
10884521705319Delivery Console 200X
10884521705296Delivery Console 200LD-V
20884521700724Room Scanner For use with the Situate Detection Console 200X
10884521700703Detection Console 200X
10884521700666Delivery Scanner For use with Situate Delivery Console 200LD-V
10884521700659Delivery Console 200LD-V
10884521700642Body Scanner Lite For use with the Situate Detection Console 200E and Console 200X
20884521700601Gauze - RF and X-ray Detectable USP Type VII, 16 Ply
10884521709874Sterile Drape For use with Situate Room Scanner
20884521700687Sterile Drape For use with Situate Extremity Scanner and Delivery Scanner
20884521701165Tonsil Sponge - RF and X-ray Detectable Tape Strung - Cotton Filled
20884521700793Gauze-RF and X-ray Detectable USP Type VII, 12 Ply. Caution: For Manufacturing, Processing or Re
20884521721767Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
20884521709833OR Towel - RF and X-ray Detectable Green
20884521706948Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
20884521706931Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
20884521706924Laparotomy Sponge-RF and X-ray Detectable Unwashed. Caution: For Manufacturing, Processing or Re
20884521706917Laparotomy Sponge-RF and X-ray Detectable Ring. Caution: For Manufacturing, Processing or Repack
20884521706900Laparotomy Sponge-RF and X-ray Detectable No Loop. Caution: For Manufacturing, Processing or Rep
20884521706894Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
20884521706887Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
20884521706870Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
20884521706863Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.
20884521701233Vaginal Packing - RF and X-ray Detectable Folded
20884521701226Vaginal Packing - RF and X-ray Detectable Folded
20884521701219Vaginal Packing - RF and X-ray Detectable Folded
20884521701202Vaginal Packing - RF and X-ray Detectable Folded
20884521701196Vaginal Packing - RF and X-ray Detectable Roll
20884521701189Vaginal Packing - RF and X-ray Detectable Folded
20884521701172Vaginal Packing - RF and X-ray Detectable Roll
20884521701158Tonsil Sponge - RF and X-ray Detectable Tape Strung, Cotton Filled
20884521701141Tonsil Sponge - RF and X-ray Detectable Tape Strung, Cotton Filled
20884521701134Tonsil Sponge - RF and X-ray Detectable Tape Strung, Cotton Filled
20884521701127Tonsil Sponge - RF and X-ray Detectable Tape Strung, Cotton Filled
20884521701110Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled
20884521701103Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled
20884521701097Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled
20884521701080Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled
20884521701073Tonsil Sponge - RF and X-ray Detectable Double Strung, Cotton Filled
20884521701042OR Towel - RF and X-ray Detectable White
20884521701035OR Towel -RF and X-ray Detectable Blue
20884521701028Perineal Packing - RF and X-ray Detectable Roll
20884521701011Perineal Packing - RF and X-ray Detectable Roll
20884521701004Laparotomy Sponge - RF and X-ray Detectable Pre-washed
20884521700991Laparotomy Sponge - RF and X-ray Detectable Pre-washed

Trademark Results [Situate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SITUATE
SITUATE
88381342 not registered Live/Pending
Covidien LP
2019-04-11
SITUATE
SITUATE
86768303 not registered Live/Pending
Covidien LP
2015-09-25

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