AccessGUDID - DEVICE: Oasis (D830OM3090)

GUDID

Device Identifier (DI) Information

Brand Name: Oasis
Version or Model: OM3090
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMD Medicom Inc

Primary DI Number: D830OM3090
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: Oasis P646 HS 3"x9" (1200/CS)

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
13735	Sterilization packaging, single-use	A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953829	000

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: 12f912e7-0106-4660-b597-edd3a2b49d28
Public Version Date: March 06, 2025
Public Version Number: 5
DI Record Publish Date: April 13, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
D830OM30902	6	D830OM30901		In Commercial Distribution	CARDBOARD BOX
D830OM30901	200	D830OM3090		In Commercial Distribution	CARDBOARD BOX

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 9052711523
Email: accounting@gsmedicalpackaging.com

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