FDA.report

Medline

Primary DI
10080196734658
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS9656
Catalog number
MDS9656
Device description
THERMOMETER,RECTAL,STANDARD,F/C,BULK
Published
2016-10-14
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
false

Related Records

Contact Domains

Product Codes

CodeName
FLLThermometer, electronic, clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10080196734658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1008019673465810080196734658

GMDN Terms

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

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
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
true
Sterilization required before use
false

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