FDA.reportPublic FDA data

ImaJin

Primary DI
05701780339032
Brand
ImaJin
Company
Coloplast A/S
Model
BCHF62
Catalog number
BCHF62
Published
2024-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FADStent, ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FADStent, UreteralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05701780339032PackageGS11In Commercial Distribution
05701780339049PackageGS134In Commercial Distribution
05701780339025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05701780339032057017803390325701780339032
05701780339049057017803390495701780339049
05701780339025057017803390255701780339025

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Length20Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932778268SpeediCath Flex Set28941289412026-02-05
05708932778275SpeediCath Flex Set28942289422026-02-05
05708932778282SpeediCath Flex Set28946289462026-02-05
03600040963876ColoplastAC5904AC59042026-01-30
03600040963944ColoplastAC5905AC59052026-01-30
03600040964026ColoplastAC5906AC59062026-01-30
03600040964095ColoplastAC5907AC59072026-01-30
03600040964170ColoplastAC5908AC59082026-01-30
03600040964231ColoplastAC5909AC59092026-01-30
03600040964293ColoplastAC5910AC59102026-01-30
03600040964361ColoplastAC5911AC59112026-01-30
03600040964415ColoplastAC5912AC59122026-01-30
03600040964651ColoplastAC5C07AC5C072026-01-30
03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450721206ReSolve ConvertX®Merit Medical Systems, Inc.FAD2026-03-05
10884450721176ReSolve ConvertX®Merit Medical Systems, Inc.FAD2026-02-05
08714729058632Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729058953Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729297253Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729297352Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729297611Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729339830Percuflex™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729424123Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729424222Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729765370Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729765684Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729766421Polaris™ UltraBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729766575Polaris™ UltraBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729766582Polaris™ UltraBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729774129Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729774617Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729774648Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729775997Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776017Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776116Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776321Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776352Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776574Contour™BOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729776949Percuflex™ PlusBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777465Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777540Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777601Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777663Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24
08714729777670Polaris™ LoopBOSTON SCIENTIFIC CORPORATIONFAD2015-09-24