FDA.report

Hopkins Medical Products®

Primary DI
00817643021978
Brand
Hopkins Medical Products®
Company
HOPKINS UNIFORM COMPANY
Model
571112
Catalog number
571112
Device description
Single Use Clinical Thermometer 100/PK
Published
2018-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00817643021978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817643021978008176430219788176430219780817643021978

GMDN Terms

TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)835-1995customerservice@hopkinsmedical.net

Regulatory Flags

DUNS number
003080678
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00817643021640Hopkins Medical Products®698545LF698545LF2018-09-28
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00817643022241Hopkins Medical Products®6153506153502018-09-28
00817643022258Hopkins Medical Products®6200676200672018-09-28
00817643020155Hopkins Medical Products®34203342032018-09-28
00817643020162Hopkins Medical Products®34204342042018-09-28

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