AccessGUDID - DEVICE: Omnipod 5 Pod (10385083000114)

GUDID

Device Identifier (DI) Information

Brand Name: Omnipod 5 Pod
Version or Model: POD-BLE-H1-520
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Insulet Corporation

Primary DI Number: 10385083000114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051334402 *Terms of Use

Device Description: Omnipod 5 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?
60770	Ambulatory insulin infusion pump/interstitial glucose monitoring system	An assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QFG	Alternate Controller Enabled Insulin Infusion Pump
QJI	Interoperable Automated Glycemic Controller

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 83f9e052-d144-4469-8ea5-c1bc6b9937e5
Public Version Date: July 29, 2024
Public Version Number: 4
DI Record Publish Date: February 25, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10385083000213	5	10385083000114	In Commercial Distribution	5 Pack Box
10385083000138	10	10385083000114	In Commercial Distribution	10 Pack Box
20385083000210	5	10385083000114	In Commercial Distribution	5 Pack Box
20385083000135	10	10385083000114	In Commercial Distribution	10 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: 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: 1-800-591-3455
Email: RegulatoryAffairs@insulet.com

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