AccessGUDID - DEVICE: Transonic (00877466002141)

GUDID

Device Identifier (DI) Information

Brand Name: Transonic
Version or Model: HQD3FMV
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TRANSONIC SYSTEMS INC.

Primary DI Number: 00877466002141
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101317451 *Terms of Use

Device Description: No description.

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:	No
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?
61341	Surgical anti-adhesion material, implantable, non-bioabsorbable	A non-bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) of one internal body part/tissue to another following a surgical procedure. The device is typically implanted during abdominal, pelvic, or spinal surgery to reduce the incidence of adhesions between adjacent anatomical structures. It is typically made of a single or composite polymer (e.g., hydrogel) in the form of a barrier membrane or fluid dressing; neither antimicrobials nor pharmaceuticals are included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DPW	Flowmeter, Blood, Cardiovascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K872048	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Hydrogen Peroxide
Moist Heat or Steam Sterilization

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: 6cdfc1cb-a76b-491f-bc3d-3ce34f9e79a8
Public Version Date: December 20, 2022
Public Version Number: 2
DI Record Publish Date: October 08, 2020

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

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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