GENTLECATH

GUDID 00768455207169

GENTLECATH AIR FEM V2.0 CH12 1X10PK US

CONVATEC, PURCHASING DEPARTMENT

Single-administration urethral drainage catheter

• Primary Device ID: 00768455207169
• NIH Device Record Key: a172ea5d-c116-468d-a9c9-a8269ca78a97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENTLECATH
• Version Model Number: 510604
• Company DUNS: 809784593
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com
• Phone: +18004228811
• Email: cic12@convatec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768455207152 [Primary]
GS1	00768455207169 [Package]; Contains: 00768455207152; Package: [10 Units]; In Commercial Distribution
GS1	00768455207176 [Package]; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232665

FDA Product Code

• EZD: Catheter, straight

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-15
• Device Publish Date: 2024-04-05

On-Brand Devices [GENTLECATH]

• 00768455145607: FEMALE CATHETER CH16X6.5 IN
• 00768455145591: FEMALE CATHETER CH14X6.5 IN
• 00768455145584: FEMALE CATHETER CH12X6.5 IN
• 00768455145577: FEMALE CATHETER CH10X6.5 IN
• 00768455145560: FEMALE CATHETER CH08X6.5 IN
• 70768455153847: GENTLECATH LOWFRIC TMNN CH18
• 70768455153830: GENTLECATH LOWFRIC TMNN CH16
• 70768455153823: GENTLECATH LOWFRIC TMNN CH14
• 70768455153816: GENTLECATH LOWFRIC TMNN CH12
• 70768455153809: GENTLECATH LOWFRIC TMNN CH10
• 70768455153793: GENTLECATH LOWFRIC TMNN CH08
• 30768455143611: FEMALE GENTLECATH TPE CH16X07 IN
• 30768455143604: FEMALE GENTLECATH TPE CH14X07 IN
• 30768455143598: FEMALE GENTLECATH TPE CH12X07 IN
• 30768455143581: FEMALE GENTLECATH TPE CH10X07 IN
• 30768455143574: FEMALE GENTLECATH TPE CH08X07 IN
• 04026704582556: CVT GENTLECATH CLOSED FEM CH14
• 04026704582549: CVT GENTLECATH CLOSED SOFT CH14
• 04026704582532: CVT GENTLECATH CLOSED RDRUB CH16
• 04026704582525: CVT GENTLECATH CLOSED RDRUB CH14
• 04026704582518: CVT GENTLECATH CLOSED TMNN CH16
• 04026704582501: 421434
• 04026704582495: CVT GENTLECATH CLOSED TMNN CH12
• 04026704582488: CVT GENTLECATH CLOSED CH16
• 04026704582471: CVT GENTLECATH CLOSED CH14
• 04026704582464: CVT GENTLECATH CLOSED CH12
• 04026704582457: CVT GENTLECATH CLOSED CH10
• 04026704582440: CVT GENTLECATH CLOSED CH08
• 04026704582433: CVT GENTLECATH CLOSED FEM CH14 KIT
• 04026704582426: CVT GENTLECATH CLOSED RDRUBTMNN CH14 KIT
• 04026704582419: CVT GENTLECATH CLOSED RDRUB CH16 KIT
• 04026704582402: CVT GENTLECATH CLOSED RDRUB CH14 KIT
• 04026704582396: CVT GENTLECATH CLOSED RDRUB CH12 KIT
• 04026704582389: CVT GENTLECATH CLOSED TMNN CH16 KIT
• 04026704582372: CVT GENTLECATH CLOSED TMNN CH14 KIT
• 04026704582365: CVT GENTLECATH CLOSED TMNN CH12 KIT
• 04026704582358: CVT GENTLECATH CLOSED SOFT CH14 KIT
• 04026704582341: CVT GENTLECATH CLOSED SOFT CH12 KIT
• 04026704582334: CVT GENTLECATH CLOSED CH18 KIT
• 04026704582327: CVT GENTLECATH CLOSED CH16 KIT
• 04026704582310: CVT GENTLECATH CLOSED CH14 KIT
• 04026704582303: CVT GENTLECATH CLOSED CH12 KIT
• 04026704582297: CVT GENTLECATH CLOSED CH10 KIT
• 04026704582280: CVT GENTLECATH CLOSED CH08 KIT
• 04026704582273: CVT GENTLECATH CLOSED CH06 KIT
• 04026704582266: CVT GENTLECATH IC CATH INSERT SUPPLIES KIT
• 00768455198948: GENTLECATH AIR MEN COUDE CH18 1X10 US
• 00768455198917: GENTLECATH AIR MEN COUDE CH16 1X10 US
• 00768455198887: GENTLECATH AIR MEN COUDE CH14 1X10 US
• 00768455198856: GENTLECATH AIR MEN COUDE CH12 1X10 US