FDA.reportPublic FDA data

Procellera Single Layer

Primary DI
00810198030310
Brand
Procellera Single Layer
Company
ARTHREX, INC.
Model
"12"" x 12"""
Catalog number
VSR-1212
Device description
"Procellera Single Layer Rx 12"" x 12"""
Published
2022-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160783000ProcelleraVomaris Innovations, Inc.2016-09-07FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810198030358PackageGS11In Commercial Distribution
00810198030365PackageGS12In Commercial Distribution
00810198030310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810198030358008101980303588101980303580810198030358
00810198030365008101980303658101980303650810198030365
00810198030310008101980303108101980303100810198030310

GMDN Terms#

Term, Definition table
TermDefinition
Portable pneumatic high-frequency ventilatorA pneumatically-powered device designed to be easily moved/mounted and intended to provide long-term support or therapeutic alveolar ventilation for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs using a frequency that is considerably higher than physiological breathing rates and a tidal volume less than or equal to the anatomic dead space (percussive ventilation), typically through an endotracheal (ET) tube, tracheostomy cannula, or mask. It typically includes a control system and alarms, sometimes with additional features (e.g., humidification).

Contacts#

Phone, Email table
PhoneEmail
(480) 921-4948customerservice@vomaris.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867007482Arthrex®AR-13100-05.0SAR-13100-05.0S2017-01-20
00888867007529Arthrex®AR-13100-09.0SAR-13100-09.0S2017-01-20
00888867007567Arthrex®AR-13100-11.0SAR-13100-11.0S2017-01-20
00888867007604Arthrex®AR-13100-15.0SAR-13100-15.0S2017-01-20
00888867007628Arthrex®AR-13100-17.5SAR-13100-17.5S2017-01-20
00888867008564Arthrex®AR-13200-03.0SAR-13200-03.0S2017-01-20
00888867204041Arthrex®AR-8952XLSAR-8952XLS2017-07-18
00888867210424Arthrex®AR-8933L-26SAR-8933L-26S2017-08-31
00888867210431Arthrex®AR-8933L-28SAR-8933L-28S2017-08-31
00888867210448Arthrex®AR-8933L-30SAR-8933L-30S2017-08-31
00888867210462Arthrex®AR-8933L-34SAR-8933L-34S2017-08-31
00888867210479Arthrex®AR-8933L-36SAR-8933L-36S2017-08-31
00888867210493Arthrex®AR-8933L-40SAR-8933L-40S2017-08-31
00888867251960Arthrex®AR-8958-01SAR-8958-01S2017-11-28
00888867266872Arthrex®AR-8952PPLAR-8952PPL2017-03-28
00888867266896Arthrex®AR-8952PSRAR-8952PSR2017-03-28
00888867266957Arthrex®AR-8952PPRAR-8952PPR2017-03-28
00888867371828Arthrex®AR-8924SAR-8924S2023-05-25
00888867251939Arthrex®AR-8958-02AR-8958-022017-02-15
00888867279285Arthrex®AR-7249-12-1AR-7249-12-12017-12-01

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