AccessGUDID - DEVICE: Accu-Chek Spirit Cartridge (04015630882755)

GUDID

Device Identifier (DI) Information

Brand Name: Accu-Chek Spirit Cartridge
Version or Model: 04949935001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 04949935001
Company Name: Roche Diabetes Care GmbH

Primary DI Number: 04015630882755
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2022
Device Count: 5
Labeler D-U-N-S® Number*: 313212471 *Terms of Use

Device Description: Accu-Chek Spirit 3.15ml Cart. Sys. 5pcs

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):	No
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?
35838	Ambulatory insulin infusion pump reservoir	An insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZG	Pump, Infusion, Insulin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042887	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: c4b3ac8c-fc74-4479-99de-3566b5c5281c
Public Version Date: July 25, 2023
Public Version Number: 5
DI Record Publish Date: August 26, 2016