DEVICE: Aveta Waste Bag. 6L (00850006759118)

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Device Record History
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Device Identifier (DI) Information
Aveta Waste Bag. 6L
205-105
In Commercial Distribution
205-105
MEDITRINA, INC.
00850006759118
GS1

1
080570262 *Terms of Use
Aveta Waste Bag. 6L, for use with Aveta System
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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?
58982 Surgical tissue/fluid collection bag, non-sterile
A non-sterile flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. This is a single-use device intended to be sterilized prior to use.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
HIH Hysteroscope (And Accessories)
HIG Insufflator, Hysteroscopic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K190372 000
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
2fb2564d-d5c6-4cb6-b5f4-d50f07552395
December 06, 2019
1
November 28, 2019
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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
00850006759217 12 00850006759118 In Commercial Distribution Carton
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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

[?]
No Customer Contact currently defined
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