AccessGUDID - DEVICE: SYNCHROMED® II (00763000634094)

GUDID

Device Identifier (DI) Information

Brand Name: SYNCHROMED® II
Version or Model: 8637-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000634094
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796986144 *Terms of Use

Device Description: PUMP 8637-20 SM II 20ML EMAN SYMBL

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
46024	Implantable intrathecal infusion pump, programmable	A battery-powered programmable device designed to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant origin. This implantable infusion pump (IIP) delivers drug doses from its implanted refillable reservoir which is controlled by drug concentration and/or by radio-frequency (RF) signals from an external programming device. The drug reservoir, usually implanted under the skin of the lower abdomen, is typically connected to a catheter placed into the spinal fluid space.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LKK	Pump, infusion, implanted, programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P860004	378
P860004	380
P860004	387

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 59 and 86 Degrees Fahrenheit
Handling Environment Temperature: between 5 and 55 Degrees Celsius
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between 41 and 131 Degrees Fahrenheit
Special Storage Condition, Specify: Do not freeze
Special Storage Condition, Specify: Keep away from magnets

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Reservoir Volume 20 ML

Device Record Status

Public Device Record Key: 6b71927c-5ca1-47b4-8d5b-c3f26b45a681
Public Version Date: April 03, 2024
Public Version Number: 3
DI Record Publish Date: August 11, 2022

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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