PCA Lockbox 250 Strap and Pouch

GUDID 27290109151650

EITAN MEDICAL LTD

Narcotics security storage cabinet

Primary Device ID	27290109151650
NIH Device Record Key	f018b30c-02e3-48be-be30-488fe8415bc7
Commercial Distribution Status	In Commercial Distribution
Brand Name	PCA Lockbox 250 Strap and Pouch
Version Model Number	15063-000-0004
Company DUNS	533108028
Company Name	EITAN MEDICAL LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290109151653 [Primary]
GS1	27290109151650 [Package] Contains: 17290109151653 Package: [24 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192860

FDA Product Code

MRZ	Accessories, Pump, Infusion

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-03-27
Device Publish Date	2024-03-19

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