DEVICE: MEDLINE (10193489181715)

Device Identifier (DI) Information

MEDLINE
ERKSMOKE4000
In Commercial Distribution
ERKSMOKE4000
MEDLINE INDUSTRIES, INC.
10193489181715
GS1

1
025460908 *Terms of Use
PENCIL, CAUTERY, SILICONE, SMOKE EVAC, R
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
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?
47998 Surgical fluid/smoke waste management system
An assembly of devices designed to collect and dispose of both surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a mains electricity (AC-powered) mobile suction unit and a fixed disposal unit. The suction unit uses negative pressure at the site of intervention to collect/filter the fluid/smoke in its containers and filters; it is attached to the disposal unit for automatic container emptying and cleaning. The system is used in the operating room (OR), pathology and surgical centres, and doctor's offices to minimize healthcare worker exposure to harmful fluids/smoke.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEI Electrosurgical, cutting & coagulation & accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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 in a clean, cool and dry place. Handle with care to avoid damage to the packaging and its content during transportation and storage.
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Clinically Relevant Size

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

16df812f-d25b-450a-8a73-aeb2580fd851
January 16, 2025
1
January 08, 2025
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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
20193489181712 10 10193489181715 In Commercial Distribution BX
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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
Yes
No
No CLOSE

Customer Contact

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