FDA.reportPublic FDA data

Rapr Round

Primary DI
07613327261400
Brand
Rapr Round
Company
STRYKER CORPORATION
Model
8001-061-660
Catalog number
8001-061-660
Published
2016-12-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DWJSystem, thermal regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57613327261405PackageGS15Not in Commercial Distribution
07613327261400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332726140557613327261405
07613327261400076133272614007613327261400

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-fluid core temperature regulation system pad, reusableAn underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated, as part of an external circulating-fluid core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric). It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit140 Degrees Fahrenheit

Regulatory Flags#

DUNS number
078470558
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327635096InZone ISTIST345100960IST3451009602026-07-08
07613327638233Omnicurve10320150001032-015-0002024-09-03
07613327554724Omnicurve1033-130-0001033-130-0002023-11-07
07613327554687Omnicurve1033-115-0001033-115-0002022-04-12
07613327554700Omnicurve1033-120-0001033-120-0002022-04-12
07613327638226Omnicurve10330150001033-015-0002024-09-03
07613327638240Omnicurve10320200001032-020-0002024-09-03
07613327638257Omnicurve10330300001033-030-0002024-09-03
07613327638431Omnicurve10330200001033-020-0002024-09-03
07613327638448Omnicurve10320300001032-030-0002024-09-03
07613327554649Omnicurve1032-130-0001032-130-0002023-11-02
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327554663Omnicurve1032-120-0001032-120-0002022-04-12
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
04546540722768WingspanM003WS0250090M003WS02500902015-05-29
04546540722775WingspanM003WS0250150M003WS02501502015-05-29
04546540722782WingspanM003WS0250200M003WS02502002015-05-29
04546540722799WingspanM003WS0300090M003WS03000902015-05-29
04546540722805WingspanM003WS0300150M003WS03001502015-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09332017002991CocoonCARE ESSENTIALS PTY LTDDWJ2026-04-29
09332017004131CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
09332017004155CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
10197344129072MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
10197344129089MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
08719867002639Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
08719867002653Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
09332017002861CocoonCARE ESSENTIALS PTY LTDDWJ2024-12-20
09332017003257CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003295CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003301CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003318CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003325CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003332CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003349CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
08719867002646Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
08719867002660Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
10193489134773MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10193489134780MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10193489134797MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012770MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012817MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012831MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344013401MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012794MedlineMEDLINE INDUSTRIES, INC.DWJ2024-04-30
09332017002885CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017002892CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017000645CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017002168CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017001178CocoonCARE ESSENTIALS PTY LTDDWJ2021-06-01