AccessGUDID - DEVICE: Omnipod DASH Pod (10385082000023)

GUDID

Device Identifier (DI) Information

Brand Name: Omnipod DASH Pod
Version or Model: POD-BLE-11-520
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Insulet Corporation

Primary DI Number: 10385082000023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051334402 *Terms of Use

Device Description: DASH Pod

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:	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?
35983	Ambulatory insulin infusion pump, electronic	A portable, battery-powered, electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. The pump infuses microvolume pulses and/or bolus doses of insulin subcutaneously, typically into the abdomen, through a needle or catheter (not included).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LZG	Pump, Infusion, Insulin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180045	000

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 Atmospheric Pressure: between 700 and 1060 KiloPascal
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9c3a70fa-e8a8-4ee0-8c96-000616ba7246
Public Version Date: July 29, 2024
Public Version Number: 3
DI Record Publish Date: August 01, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20385082000020	10	10385082000023		In Commercial Distribution	10 Pack Box
20385082000051	5	10385082000023		In Commercial Distribution	5 Pack Box

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: 10385082000023
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: 1-800-591-3455
Email: xxxx@xxx.com

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