FDA.reportPublic FDA data

Adapt

Primary DI
00610075077403
Brand
Adapt
Company
HOLLISTER INCORPORATED
Model
7740
Catalog number
7740
Device description
Stoma Lubricant
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXBCOLLECTOR, OSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXBCollector, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075077407PackageGS11In Commercial Distribution
00610075077403PrimaryGS10
00610075072132Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007507740720610075077407
00610075077403006100750774036100750774030610075077403
00610075072132006100750721326100750721320610075072132

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricantA substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-4060cs@hollister.com

Regulatory Flags#

DUNS number
005527098
Device count
10
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
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
00610075098217Hollister982198212022-12-01
00610075098224Hollister982298222022-12-01
00610075098231Hollister982398232022-12-01
00610075098804Hollister988098802022-12-01
00610075040070InstaFlo330162016-09-21
00610075179626ActiFlo320042016-09-21
00610075179633ActiFlo320052016-09-21
00610075179640ActiFlo320062016-09-21
00610075179657ActiFlo320072016-09-21
10610075180292Advance Plus Pocket93104IC93104IC2016-09-21
10610075180308Advance Plus Pocket93124IC93124IC2016-09-21
10610075180315Advance Plus Pocket93144IC93144IC2016-09-21
10610075180322Advance Plus Pocket93164IC93164IC2016-09-21
00610075077243Hollister772477242022-12-01
00610075077281Hollister772877282022-12-01
00610075095667VaPro Plus Pocket Kit79089K79089K2024-07-15
00610075095674VaPro Plus Pocket Kit79109K79109K2024-07-15
00610075095681VaPro Plus Pocket Kit79129K79129K2024-07-15
00610075095698VaPro Plus Pocket Kit79149K79149K2024-07-15
00610075095704VaPro Plus Pocket Kit79169K79169K2024-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00618029980274Stryker Fecal Management SystemSAGE PRODUCTS, LLCEXB2023-03-07
00610075029839New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029846New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029853New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029860New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029877New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029884New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029891New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029907New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029914New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029921New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075031849HollisterHOLLISTER INCORPORATEDEXB2022-12-01
00610075031863HollisterHOLLISTER INCORPORATEDEXB2022-12-01
00610075033263Karaya 5HOLLISTER INCORPORATEDEXB2022-12-01
00610075037742PouchkinsHOLLISTER INCORPORATEDEXB2022-12-01
00610075051762New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051779New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051786New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051793New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051809New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051816New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051823New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051830New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051847New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051854New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051861New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051984New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051991New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075052004New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075052011New ImageHOLLISTER INCORPORATEDEXB2022-12-01