VYGON

Primary DI
33660812085473
Brand
VYGON
Company
VYGON
Model
39.29.01
Catalog number
00392901
Device description
Birthing ball protective cover
Published
2025-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPDTUBE, FEEDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPDTube, FeedingGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
33660812085473PackageGS18In Commercial Distribution
53660812085477PackageGS14In Commercial Distribution
03660812085472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3366081208547333660812085473
5366081208547753660812085477
03660812085472036608120854723660812085472

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
392994778
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
03660812123075VYGON5804.04005804042021-06-09
03660812123082VYGON5804.08005804082021-06-09
03660812141536VYGON115.11000115112023-08-24
03660812141567VYGON115.0900001150902023-07-03
03660812094535VYGON368.47000368472025-03-31
03660812106627VYGON1366.167100136616712025-03-31
03660812114844VYGON1366.067100136606712025-03-31
03660812118910VYGON1366.107100136610712025-03-31
03660812118927VYGON1366.107200136610722025-03-31
03660812118941VYGON1366.087100136608712025-03-31
03660812118958VYGON1366.087200136608722025-03-31
03660812126397VYGON1366.127100136612712025-03-31
03660812126403VYGON1366.127200136612722025-03-31
03660812145329VYGON1362.127200136212722025-03-31
03660812145923VYGON1362.107100136210712025-03-31
03660812145930VYGON1362.107200136210722025-03-31
03660812147088VYGON1366.147100136614712025-03-31
03660812154222VYGON1362.067100136206712025-03-31
53660812094530VYGON368.47000368472025-03-31
33660812106628VYGON1366.167100136616712025-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08015262037390VYGONVygon CorporationFPD2024-05-08
08015262039943VYGONVygon CorporationFPD2024-05-08
08015262022266VYGONVygon CorporationFPD2024-03-22
10680651456813HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456844HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456868HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456875HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456899HalyardAvanos Medical, Inc.FPD2018-10-04
10680651456912HalyardAvanos Medical, Inc.FPD2018-10-04
10680651457025HalyardAvanos Medical, Inc.FPD2018-10-04
10680651457100HalyardAvanos Medical, Inc.FPD2018-10-04
10680651457179HalyardAvanos Medical, Inc.FPD2018-10-04
10817522010151Ameritus ENFitKENTEC MEDICAL, INC.FPD2018-06-04
10817522010182Ameritus ENFitKENTEC MEDICAL, INC.FPD2018-06-04
10817522010205Ameritus ENFitKENTEC MEDICAL, INC.FPD2018-06-04
10817522011554Ameritus KENTEC MEDICAL, INC.FPD2018-06-04
10817522011561Ameritus KENTEC MEDICAL, INC.FPD2018-06-04
10817522011684Ameritus KENTEC MEDICAL, INC.FPD2018-06-04
10817522011691Ameritus KENTEC MEDICAL, INC.FPD2018-06-04
10680651457513HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457544HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457568HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457582HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457605HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457629HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457650HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457681HalyardAvanos Medical, Inc.FPD2018-01-19
10680651457704HalyardAvanos Medical, Inc.FPD2018-01-19
10680651466430HalyardAvanos Medical, Inc.FPD2018-01-19
10680651466447HalyardAvanos Medical, Inc.FPD2018-01-19