AccessGUDID - DEVICE: Adler Instrument Company (00810123206858)

GUDID

Device Identifier (DI) Information

Brand Name: Adler Instrument Company
Version or Model: 41-0383
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Adler, Inc.

Primary DI Number: 00810123206858
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830141235 *Terms of Use

Device Description: Heparin Flushing NDL 2

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):	Yes
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?
62317	Vascular irrigation cannula, coronary artery, reusable	A rigid or semi-rigid tube designed to be surgically inserted, temporarily, into a coronary artery to serve as a channel for the transport of fluid during a surgical intervention. It is typically intended for the infusion and/or perfusion of fluids in diagnostic and/or surgical procedures, such as cardiopulmonary bypass, and to help avoid ischemia. Insertion is typically achieved with the use of a removable stylet or trocar blade. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEA	Cannula, Surgical, General & Plastic Surgery

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
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: 76ebf384-5a9f-45d2-b294-4ef149cd1a0c
Public Version Date: March 22, 2024
Public Version Number: 1
DI Record Publish Date: March 14, 2024

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

Customer Contact

[?]

Phone: 8772416747
Email: orders@theadlerinstruments.com

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