AccessGUDID - DEVICE: ARROW (30801902092176)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN000321
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IAP-0500D
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 30801902092176
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: AUTOCAT2 WAVE GERMAN

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
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?
36340	Intra-aortic balloon pump	An electrically-powered device intended to inflate/deflate the balloon of an intra-aortic balloon catheter (not included) to assist cardiac function. The device monitors the patient’s electrocardiogram (ECG) and blood pressure to inflate/deflate the balloon in synchrony with the cardiac cycle, so that the balloon inflates after a cardiac contraction to increase perfusion of the coronary arteries and deflates before the next contraction to avoid obstructing aortic outflow. The device typically includes a main unit which incorporates a helium cylinder for balloon inflation/deflation, a screen, and controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSP	System, balloon, intra-aortic and control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060309	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
Handling Environment Humidity: between 15 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between -15 and 40 Degrees Celsius
Storage Environment Humidity: between 15 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -15 and 40 Degrees Celsius
Special Storage Condition, Specify: Store between -15 - 40°C (5 - 104°F)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2fead005-bd2f-4a97-99cf-e1368c3e3b75
Public Version Date: July 30, 2025
Public Version Number: 10
DI Record Publish Date: October 16, 2015

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: Yes
DM DI Number: 00801902092175
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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