FDA.reportPublic FDA data

WROOTBOL NOTIPATCH

Primary DI
18800105200157
Brand
WROOTBOL NOTIPATCH
Company
ONE POWER
Model
DR-TZ+365
Device description
Thermometer, colour-indicating
Published
2021-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FQZThermometer, Clinical Color Change

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQZThermometer, Clinical Color ChangeGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800105200157PackageGS1800In Commercial Distribution
08800105200150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880010520015718800105200157
08800105200150088001052001508800105200150

GMDN Terms#

Term, Definition table
TermDefinition
Colour-indication patient thermometerA device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. The device records body temperature using heat sensitive chemical cells (dots) which are sealed at the end of a plastic or metal strip. Body heat causes a colour change in the heat sensitive chemicals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694627986
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800105200150WROOTBOL NOTIPATCHDR-TZ+3652021-05-17
08800105200020Dr.Tempzone+DR-TZ-US22020-11-02
08800105200037Dr.Tempzone+DR-TZ-US12020-11-02
18800105200027Dr.Tempzone+DR-TZ+3652020-11-02
18800105200034Dr.Tempzone+DR-TZ+3652020-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00016944401360 NexTemp MEDICAL INDICATORS INCFQZ2025-07-17
00016944401377 NexTemp MEDICAL INDICATORS INCFQZ2025-07-17
10016944401107 NexTemp MEDICAL INDICATORS INCFQZ2025-07-17
00016944401490 NexTempMEDICAL INDICATORS INCFQZ2025-05-08
00016944401506 NexTempMEDICAL INDICATORS INCFQZ2025-05-08
00016944701514TraxItMEDICAL INDICATORS INCFQZ2025-05-08
10016944401480 NexTempMEDICAL INDICATORS INCFQZ2025-05-08
10016944701085TraxItMEDICAL INDICATORS INCFQZ2025-05-08
10889483570869AirLife™AIRLIFEFQZ2025-03-27
10889483570883AirLife™AIRLIFEFQZ2025-03-27
30889483570863AirLife™Sunmed Group Holdings, LLCFQZ2025-03-27
30889483570887AirLife™Sunmed Group Holdings, LLCFQZ2025-03-27
10889483570876AirLife™AIRLIFEFQZ2025-03-06
30889483570870AirLife™Sunmed Group Holdings, LLCFQZ2025-03-06
60016944401447 NexTempMEDICAL INDICATORS INCFQZ2025-02-13
20016944401463 NexTempMEDICAL INDICATORS INCFQZ2025-02-13
00016944401438 NexTempMEDICAL INDICATORS INCFQZ2024-08-29
00016944401452 NexTempMEDICAL INDICATORS INCFQZ2024-08-29
00016944401476 NexTempMEDICAL INDICATORS INCFQZ2024-08-29
20016944401432 NexTempMEDICAL INDICATORS INCFQZ2024-08-29
10016944401435 NexTempMEDICAL INDICATORS INCFQZ2024-08-29
00860447001738TitronicsTITRONICS RESEARCH & DEVELOPMENT COMPANYFQZ2024-01-18
20016944401425NexTempMEDICAL INDICATORS INCFQZ2023-11-17
10016944401176NexTempMEDICAL INDICATORS INCFQZ2023-11-17
10190752157637AirLife™VYAIRE MEDICAL, INC.FQZ2022-08-22
50190752157635AirLife™VYAIRE MEDICAL, INC.FQZ2022-08-22
00016944401346NexTempMEDICAL INDICATORS INCFQZ2021-08-30
00016944401322NexTempMEDICAL INDICATORS INCFQZ2021-08-12
00016944401339NexTempMEDICAL INDICATORS INCFQZ2021-08-12
10016944401114NexTempMEDICAL INDICATORS INCFQZ2021-08-12