AccessGUDID - DEVICE: Medline (30080196713879)

GUDID

Device Identifier (DI) Information

Brand Name: Medline
Version or Model: MDS9608
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MDS9608
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 30080196713879
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: SHEATH,THERMOMETER,RECTAL,DIGITL,PRELUB

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42391	Capillary thermometer cover	A device intended to be used as a physical barrier for an alcohol or mercury capillary thermometer to prevent cross-contamination between patients and/or environmental exposure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, electronic, clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4298f105-14a1-4cd3-a636-b24ecbc71d63
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 14, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 10080196713875 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-5463
Email: service@medline.com

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