FDA.reportPublic FDA data

Ambu

Primary DI
30817357021500
Brand
Ambu
Company
HYGIA HEALTH SERVICES, INC.
Model
002 810 001
Device description
Ambu Perfit Ace Collar
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
IQFOrthosis, Cervical-Thoracic, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQFOrthosis, Cervical-Thoracic, RigidPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30817357021500PackageGS130Not in Commercial Distribution
10817357021506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081735702150030817357021500
1081735702150610817357021506

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine collar, single-useA padded device that is worn around the neck and used to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177939027
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
10817357021704Mabis10-428-0802016-09-24
10817357021797Mabis10-426-0202016-09-24
10817357021940Mabis10-426-0802016-09-24
10817357021957Mabis10-428-0102016-09-24
10817357021995Mabis10-428-0202016-09-24
10817357021179Stryker5921-034-2352018-05-04
10817357021261Zimmer60-7070-1032018-01-15
10817357021278Zimmer60-7070-1062018-01-15
10817357021438Stryker5921-218-2352018-05-04
10817357021469Zimmer60-7070-1042018-03-02
10817357021575Zimmer60-7070-1052018-01-15
10817357021735Stryker5921-218-1352018-03-03
10817357021841Stryker5921-034-1352018-03-02
10817357021919Stryker5921-024-2352018-05-04
10817357022022Stryker5921-044-2352018-05-04
10817357022169Stryker5921-030-1352018-03-02
10817357022350Stryker5921-018-1352018-02-16
10817357022435Zimmer60-7075-1032018-02-16
10817357022442Zimmer60-7075-1062018-02-16
10817357022459Zimmer60-7075-1052018-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00645517888613TrulifeTRULIFE LIMITEDIQF2025-09-11
00645517890883TrulifeTRULIFE LIMITEDIQF2025-09-11
00645517898940TrulifeTRULIFE LIMITEDIQF2025-09-11
00645517899114TrulifeTRULIFE LIMITEDIQF2025-09-11
00645517024189TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517323831TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517323848TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517323886TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517323947TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517510729TrulifeTRULIFE LIMITEDIQF2025-09-03
00645517510743TrulifeTRULIFE LIMITEDIQF2025-09-03
08057592700094NECKLITEFLAMOR SRLIQF2025-01-27
08057592700100NECKLITEFLAMOR SRLIQF2025-01-27
08057592700117NECKLITEFLAMOR SRLIQF2025-01-27
08057592700124NECKLITEFLAMOR SRLIQF2025-01-27
08057592700131NECKLITEFLAMOR SRLIQF2025-01-27
08057592700148NECKLITEFLAMOR SRLIQF2025-01-27
00645517024172TrulifeTRULIFE LIMITEDIQF2023-06-06
00645517322674TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517322681TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517322698TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517325002TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517326306TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517326351TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517326375TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517317991TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517318004TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517318011TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517318028TrulifeTRULIFE LIMITEDIQF2022-12-31
00645517318035TrulifeTRULIFE LIMITEDIQF2022-12-31