FDA.report

CVS/Pharmacy

Primary DI
40050428357680
Brand
CVS/Pharmacy
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
K-953
Device description
30 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-contam
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40050428357680PackageGS1144In Commercial Distribution
00050428357682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4005042835768040050428357680
00050428357682000504283576820504283576820050428357682

GMDN Terms

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

Contacts

PhoneEmail
303-271-0300info@180innovations.com

Regulatory Flags

DUNS number
062312574
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

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00328785012729VicksKAZ USA, INC.FLL2025-12-16
00328785012781BraunKAZ USA, INC.FLL2025-12-16
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