AccessGUDID - DEVICE: SJM™ (05414734500029)

GUDID

Device Identifier (DI) Information

Brand Name: SJM™
Version or Model: AC-0130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AC-0130
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734500029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: SILICONE OIL

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):	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?
46220	Implantable-device lubricant	A friction-reducing substance (e.g., mineral oil) that is primarily used on implantable devices prior to implantation to lubricate surfaces for the promotion of effective function. It is typically used on the pacing leads of implantable pacemakers/defibrillators to lubricate the lead terminal pin to ease its insertion into the header connector (connection socket) of a pulse generator where it is locked into place (some leads have seal rings on the terminal pin which create friction). It is typically supplied in a small disposable tube. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWS	Implantable cardioverter defibrillator (non-CRT)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit
Handling Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bbdfa2b7-99d2-4c35-a4ff-849efc94f96e
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: February 06, 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
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
HIBCC	H758AC01300

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: +1(855)478-5833
Email: customerservice@sjm.com

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