DigniCap

Primary DI
07350002100042
Brand
DigniCap
Company
Dignitana AB
Model
S1
Catalog number
REF 13400
Published
2016-11-01
Public version status
Update
Distribution status
Not 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
07350002100042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350002100042073500021000427350002100042

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth199.4Millimeter
Height150.3Millimeter
Width186.6Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4646163090info@dignitana.com

Regulatory Flags#

DUNS number
775901619
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
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
00850036106166DigniCap® Delta800-2001800-20012022-02-02
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