DigniCap® Delta

Primary DI
00850036106166
Brand
DigniCap® Delta
Company
Dignitana AB
Model
800-2001
Catalog number
800-2001
Device description
DeltaKit 1 (Mesh bag includes Cooling Wrap, Thermal Cap, Chin Strap, Wet Brush, Spray Bottle, Headband, & Patient Guide)
Published
2022-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850036106166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850036106166008500361061668500361061660850036106166

GMDN Terms#

Term, Definition table
TermDefinition
Scalp cooling systemAn assembly of mains electricity (AC-powered) devices intended to reduce scalp hair loss associated with intravenous chemotherapy treatment by cooling the scalp to cause vasoconstriction and reduction of chemotherapy drug uptake by the follicular cells. It consists of a control unit which pumps a cooling agent to a head-worn cap containing coolant channels and temperature monitoring sensors. An insulating cap (e.g., neoprene) may be worn over the cooling cap to secure it and prevent condensation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-375-8070info@dignitana.com

Regulatory Flags#

DUNS number
775901619
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850036106005DigniCap® Delta900-1001900-10012022-02-02
00850036106036DigniCap® Delta900-2001900-20012022-02-02
00850036106074DigniCap® Delta800-1001800-10012022-02-02
00850036106173DigniCap® Delta800-2002800-20022022-02-02
00850036106180DigniCap® Delta800-2003800-20032022-02-02
00850036106234DigniCap® Delta800-1104800-11042022-02-02
00850036106319DigniCap® Delta800-1002800-10022022-02-02
00850036106326DigniCap® Delta800-1003800-10032022-02-02
00850036106333DigniCap® Delta800-1004800-10042022-02-02
00850036106159DigniCap® Delta800-1201800-12012022-02-01
00850036106197DigniCap® Delta800-1102800-11022022-02-01
00850036106210DigniCap® Delta800-1103800-11032022-02-01
00850036106289DigniCap® Delta700-1004700-10042022-02-01
00850036106296DigniCap® Delta700-1005700-10052022-02-01
00850036106302DigniCap® Delta700-1006700-10062022-02-01
00850036106258DigniCap® Delta700-1001700-10012022-01-31
00850036106265DigniCap® Delta700-1002700-10022022-01-31
00850036106272DigniCap® Delta700-1003700-10032022-01-31
07350002100011Digni C3C3 - 115 VACRef 100332016-11-01
07350002100028DigniCapXS1Ref 132002016-11-01