DEVICE: Medline (10080196810017)

Device Identifier (DI) Information

Medline
DYND30367
In Commercial Distribution
DYND30367
MEDLINE INDUSTRIES, INC.
10080196810017
GS1

1
025460908 *Terms of Use
CONTAINER,SPECIMEN,PNEU TUBE,3OZ,OR STRL
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47775 General specimen container IVD, no additive/medium
An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMH CONTAINER, SPECIMEN, STERILE
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FDA Premarket Submission

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store at room temperature.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ee1c5b58-77e6-4c5e-89d4-cf7ee534b596
November 30, 2023
1
November 22, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
40080196810018 100 10080196810017 In Commercial Distribution CS
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)633-5463
service@medline.com
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