AccessGUDID - DEVICE: NA (05415067040756)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 16000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16000
Company Name: Thoratec Corporation

Primary DI Number: 05415067040756
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070156955 *Terms of Use

Device Description: Charger

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":	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?
33658	Implant battery charger	An electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ. It is not intended to program or extract data from (read) the implanted device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJS	Stimulator, electrical, implanted, for essential tremor
NHL	Stimulator, electrical, implanted, for parkinsonian symptoms
MHY	Stimulator, electrical, implanted, for parkinsonian tremor
LGW	Stimulator, spinal-cord, totally implanted for pain relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P010032	186
P140009	087

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
Storage Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: exactly 23 Degrees Celsius
Storage Environment Temperature: exactly 73 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Special Storage Condition, Specify: Temperature excursion linits: -20°C (-4°F) to 60°C (140°F). Temperature excursions: Excursions below 15°C (59°F) or above 30°C (86°F) should be <24 hours in duration.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 141fa68b-0a3b-4081-a971-2d1f59ad5449
Public Version Date: February 19, 2024
Public Version Number: 3
DI Record Publish Date: January 04, 2023

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

Customer Contact

[?]

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

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