FDA.reportPublic FDA data

Prone Plus

Primary DI
00850018561488
Brand
Prone Plus
Company
INTERNATIONAL BIOMEDICAL, LTD.
Model
PRONE PLUS COVER - SMALL
Catalog number
989805604851
Device description
PRONE PLUS COVER - SMALL
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRPHolder, Infant Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRPHolder, Infant PositionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018561488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018561488008500185614888500185614880850018561488

GMDN Terms#

Term, Definition table
TermDefinition
Pillow cover, reusableA device made of an impermeable material that fits over a pillow, and under a pillowcase, to reduce allergen levels or for infection control. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
5128730033sales@int-bio.com

Regulatory Flags#

DUNS number
073179368
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018561006ECG Patient CableECG Patient Cable711-00142026-10-13
00850018561037Gel-E DonutGEL-E DONUT, MEDIUM (CASE OF 12)9898031963912026-10-13
00850018561044Gel-E DonutGEL-E DONUT, EXTRA SMALL (CASE OF 12)9898031963712026-10-13
00850018561051Gel-E DonutGEL-E DONUT, SMALL (CASE OF 12)9898031963812026-10-13
00850018561068SquishonSquishon 2 Gel Pillow, 12/pk9898031963612026-10-13
00850018561075SquishonSquishon Mattress9898056033012026-10-13
00850018561082SquishonSquishon 3 Gel Pillow, 12/pk9898056064612026-10-13
00850018561105WeeSpecsWeeSpecs, Small (28-34 cm), 50/pk9898056076412026-10-13
00850018561136WeeSpecsWeeSpecs Supreme Small, 50/pk9898056041612026-10-13
00850018561143WeeSpecsWeeSpecs Supreme, Medium, 50/pk9898056042112026-10-13
00850018561150WeeSpecsWeeSpecs Supreme, Preemie, 50/pk9898056076312026-10-13
00850018561167WeeSpecsWeeSpecs, Medium (> 34 cm), 50/pk9898056076512026-10-13
00850018561174WeeSpecsWEESPECS SUPREME - PREEMIE, 50/CASE9898056042012026-10-13
00850018561242NxtGen Infant Transport IncubatorNxtGen Incubator Skin Temp Sensor739-16032026-10-13
00850018561259NxtGen Infant Transport IncubatorNxtGen Incubator Phototherapy Light387-00572026-10-13
00850018561266NxtGen Infant Transport IncubatorNxtGen Incubator Heated Mattress738-24112026-10-13
00850018561457Prone PlusPRONE PLUS COVER- EXTRA SMALL9898056048412026-10-13
00850018561464Prone PlusPRONE PLUS COVER- MEDIUM9898056048612026-10-13
00850018561471Prone PlusPRONE PLUS COVER - LARGE9898056049012026-10-13
00850018561570NxtGen Infant Transport IncubatorO2 Monitor Cable, Incubator711-18602026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018561457Prone PlusINTERNATIONAL BIOMEDICAL, LTD.FRP2026-10-13
00850018561464Prone PlusINTERNATIONAL BIOMEDICAL, LTD.FRP2026-10-13
00850018561471Prone PlusINTERNATIONAL BIOMEDICAL, LTD.FRP2026-10-13
04260764840557MedibinoNEO ring – TG PUR Gel - Size L - PU 6Kluba Medical GmbHFRP2024-09-06
04260764840571MedibinoNEO ring – TG PUR Gel - Size S - PU6Kluba Medical GmbHFRP2024-09-06
04260764840649MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50Kluba Medical GmbHFRP2024-09-06
04260764840656MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50Kluba Medical GmbHFRP2024-09-06
04260764840663MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50Kluba Medical GmbHFRP2024-09-06
04260764840670MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50Kluba Medical GmbHFRP2024-09-06
04260764840687MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50Kluba Medical GmbHFRP2024-09-06
04260764840694MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50Kluba Medical GmbHFRP2024-09-06
04260764840564MedibinoNEO ring – TG PUR Gel - Size M - PU6Kluba Medical GmbHFRP2024-09-06
04260764840724MedibinoNEO ring – TG PUR Gel - Size S - PU6Kluba Medical GmbHFRP2024-09-06
04260764840809MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50Kluba Medical GmbHFRP2024-09-06
04260764840847MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50Kluba Medical GmbHFRP2024-09-06
00610570004812DANNY SLING 10-18 LBSBird & Cronin, LLCFRP2022-08-20
00610570004850DANNY SLING 2-5 LBSBird & Cronin, LLCFRP2022-08-20
00610570006755DANNY SLING 5-9 LBSBird & Cronin, LLCFRP2022-08-20
00610570007301KERRY KUDDLER 18-40 LBSBird & Cronin, LLCFRP2022-08-20