Prone Positioning Pillow 30-146-I

GUDID 10810044961055

P3 Infant 3-1/8" x 6-1/2" X 7-1/2"

GENEVA HEALTHCARE, LLC

Freestanding patient positioner, single-use
Primary Device ID10810044961055
NIH Device Record Keya1c94726-4eae-4339-90cf-c84d272dbc1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameProne Positioning Pillow
Version Model Number30-146-I
Catalog Number30-146-I
Company DUNS964459106
Company NameGENEVA HEALTHCARE, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com
Phone1-262-767-9870
Emailinfo@genevahc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810044961058 [Primary]
GS110810044961055 [Package]
Contains: 00810044961058
Package: Case [9 Units]
In Commercial Distribution

FDA Product Code

CCXSupport, Patient Position

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-28
Device Publish Date2020-07-20

On-Brand Devices [Prone Positioning Pillow]

10810044961062P3 Pediatric 3-5/8" X 8" X 9-1/4"
10810044961055P3 Infant 3-1/8" x 6-1/2" X 7-1/2"
10810044961048P3 Adult 5" X 10-1/4" X 12"

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