DEVICE: WomanCare Global Single-Valve Aspirator Accessory Kit (00853615006321)

Device Identifier (DI) Information

WomanCare Global Single-Valve Aspirator Accessory Kit
AK-SVS
In Commercial Distribution

WOMANCARE GLOBAL TRADING, INC.
00853615006321
GS1

1
064730456 *Terms of Use
Accessory kits are bagged and each kit contains: collar stop, plunger, o-ring and 2cc silicone tube. The cap, collar stop and o-ring, as components, are suitable to be reused a maximum of 25 times.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
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?
33577 Abortion suction system collection bottle
A component of an abortion (uterine) suction system designed to function as a trap to collect the products of conception from the uterus [the termination of early pregnancies (up to 12 weeks), the treatment of incomplete spontaneous abortions, the removal of retained afterbirth, menstrual regulation, or biopsy]. It is typically cylindrical in shape and connected to a wide bore tubing through which the removed material is suctioned. It may have an integrated filter made of woven textile that acts as a sieve and trap (blood passes through whilst solids are retained). This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
HHI System, Abortion, Vacuum
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
High-level Disinfectant
Liquid Chemical
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Lubricant: 2cc tube
Device Size Text, specify: Collar Stop length: 3 inches
Device Size Text, specify: Ring Diameter: 1 inch
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Device Record Status

60be1228-64ce-48fd-8a9a-4cca3ef0e77e
March 29, 2018
2
September 17, 2016
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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
No Package DIs found
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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

[?]
+1-858-314-4030
customerservice@womancareglobal.org
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