FDA.reportPublic FDA data

Sunmark

Primary DI
40038703000070
Brand
Sunmark
Company
MCKESSON CORPORATION
Model
K-955
Device description
50 pack of probe covers. A device intended to be used as a physical barrier between the patient and the probe of a thermometer to prevent cross-contamination between patients. This is a single-use device.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20038703000076PackageGS16In Commercial Distribution
40038703000070PackageGS18In Commercial Distribution
00038703000072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2003870300007620038703000076
4003870300007040038703000070
00038703000072000387030000720387030000720038703000072

GMDN Terms#

Term, Definition table
TermDefinition
Electronic thermometer probe coverA device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
303-271-0300info@180innovations.com

Regulatory Flags#

DUNS number
177667227
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00010939960139Foster & ThriveBP3NP1-3EMFT(2878056)2024-09-23
00010939960153Foster & ThriveBP3NU1-3EMFT(2878072)2024-09-23
00010939960177Foster & ThriveBP3MV1-3BMFT(2878098)2024-09-23
10010939960136Foster & ThriveBP3NP1-3EMFT(2878056)2024-09-23
10010939960150Foster & ThriveBP3NU1-3EMFT(2878072)2024-09-23
10010939960174Foster & ThriveBP3MV1-3BMFT(2878098)2024-09-23
00010939960191Foster & ThriveKD-1541.F&T2024-07-23
00010939960207Foster & ThriveK-955.F&T2024-07-23
00010939960214Foster & ThriveKD-2280.F&T2024-07-23
00010939960221Foster & ThriveKD-1540.F&T2024-07-23
00010939960238Foster & ThriveKD-1780-1.F&T2024-07-23
20010939960195Foster & ThriveKD-1541.F&T2024-07-23
20010939960201Foster & ThriveK-955.F&T2024-07-23
20010939960218Foster & ThriveKD-2280.F&T2024-07-23
20010939960225Foster & ThriveKD-1540.F&T2024-07-23
20010939960232Foster & ThriveKD-1780-1.F&T2024-07-23
00010939960160Foster & ThriveBP3NM1-3WMFT(2878080)2024-06-21
10010939960167Foster & ThriveBP3NM1-3WMFT(2878080)2024-06-21
00010939960146Foster & ThriveBP3NG1-1AMFT(2878064)2024-06-19
00010939960184Foster & ThriveBPAG1-20MFT(2878106)2024-06-18

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Primary DI, Brand, Company table
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22