FDA.reportPublic FDA data

Secure-It ™ Catheter Tube Holder

Primary DI
00840113224975
Brand
Secure-It ™ Catheter Tube Holder
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
630010XBX
Device description
Intended to provide security and patient comfort by firmly holding tubing in place
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape and bandage, adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840113224968PackageGS1100In Commercial Distribution
00840113224975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113224968008401132249688401132249680840113224968
00840113224975008401132249758401132249750840113224975

GMDN Terms#

Term, Definition table
TermDefinition
Basic skin adhesive tapeA long and narrow flexible band of fabric, plastic, paper, or other material, coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter, lamp); it is not hypoallergenic or waterproof. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00887482023402Symmetry53-16642026-02-15
00887482138373Sterion10-00-752026-02-15
00887482156186Symmetry53-1662T2026-02-15
00887482156223Symmetry53-1664T2026-02-15
20887482023376Symmetry53-16612026-02-15
10607151000100BOVIE001000102016-10-10
10607151000117BOVIE001100112016-10-10
10607151000124BOVIE001200122016-10-10
10607151001428BOVIEA1204PA1204P2016-10-12
10607151001534BovieA802EUA802EU2016-10-19
10607151001541BOVIEA1252CA1252C2016-10-12
10607151001589BovieA1255AA1255A2016-09-28
10607151002258BovieNLOTNLOT2017-02-10
10607151002579BOVIEA1254CA1254C2016-10-12
10607151004733BOVIEA1202A12022016-10-12
10607151004801BovieFSSEPFSSEP2016-09-16

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