CONMED PTCA40-03II
GUDID 30653405049627
L/W: PMS TEL;SNAP,40 INCH,3/PKG,CAP
Conmed Corporation
Electrocardiographic lead set, reusable| Primary Device ID | 30653405049627 |
| NIH Device Record Key | ae6d1066-7953-4f08-b8d3-ae020a703fd6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONMED |
| Version Model Number | PTCA40-03II |
| Catalog Number | PTCA40-03II |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| 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 | true |
| Expiration Date | false |
| 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
Operating and Storage Conditions
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30653405049627 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K933649
FDA Product Code
| DSA | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
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 | 2020-05-06 |
| Device Publish Date | 2020-04-28 |
On-Brand Devices [CONMED]
| 20845854038892 | 3DHD DUAL CHANNEL STEREO ENDOSCOPE AUTOCLAVABLE 10MM 30 DEGREE |
| 20845854038885 | 3DHD DUAL CHANNEL STEREO ENDOSCOPE 10MM 30 DEGREE |
| 20845854024888 | 3DHD DUAL CHANNEL STEREO ENDOSCOPE AUTOCLAVABLE 10MM 0 DEGREE |
| 20653405063978 | ECG Leadwires |
| 20653405063961 | ECG Leadwires |
| 20653405056673 | CONMED GOLDLINE FOOT CONTROLLED WITH ULTRACLEAN BLADE ELECTRODE SAFETY HOLSTER AND 10 FOOT (3M) |
| 20653405056291 | CONMED GOLDLINE HAND CONTROLLED WITH EXTENDED INSULATION BLADE ELECTRODE BUTTON SWITCH, SAFETY H |
| 20653405056161 | CONMED GOLDLINE FOOT CONTROLLED WITH BLADE ELECTRODE SAFETY HOLSTER AND 10 FOOT (3M) CABLE, ELEC |
| 40653405033098 | CONMED ELECTROSURGICAL HANDPIECE, REUSABLE WITH ROCKER SWITCH AND BLADE ELECTRODE |
| 40653405033081 | CONMED ELECTROSURGICAL HANDPIECE, REUSABLE WITH ROCKER SWITCH AND BLADE ELECTRODE |
| 40653405033067 | CONMED ELECTROSURGICAL HANDPIECE, REUSABLE WITH ROCKER SWITCH AND BLADE ELECTRODE |
| 20653405032059 | CONMED ACCESSORY ELECTRODE, 6 INCH (15CM) FLAT BLADE WITH EXTENDED INSULATION |
| 20653405032035 | CONMED ELECTROSURGICAL ACCESSORY ELECTRODE, NEEDLE ELECTRODE |
| 20653405010255 | CONMED ELECTROSURGICAL ACCESSORY, BALL ELECTRODE, 3MM, EXTENDED SHAFT |
| 20653405010248 | CONMED ELECTROSURGICAL ACCESSORY, BALL ELECTRODE, 2MM, EXTENDED SHAFT |
| 20653405010231 | Loop Excision Electrode 20mm x 10mm |
| 20653405010224 | Loop Excision 15mm x 10mm |
| 20653405010217 | Loop Excision 12mm x 8mm |
| 20653405003431 | CONMED ELECTROSURGICAL ACCESSORY ELECTRODE, 6 INCH FLAT BLADE |
| 20653405003400 | CONMED ELECTROSURGICAL ACCESSSORY ELECTRODE, FLAT BLADE WITH EXTENDED INSULATION |
| 20653405003363 | CONMED ELECTROSURGICAL ACCESSORY ELECTRODE, NEEDLE ELECTRODE |
| 20653405003349 | CONMED ELECTROSURGICAL ACCESSORY ELECTRODE, STANDARD FLAT BLADE |
| 20653405003332 | CONMED ACCESSORY ELECTRODE, STANDARD FLAT BLADE |
| 20653405003325 | CONMED ACCESSORY ELECTRODE, HEAVY FLAT BLADE |
| 20653405003158 | DISPOSABLE SAFETY HOLSTER |
| 20653405002465 | CONMED DISPOSABLE ELECTROSURGICAL SAFETY HOLSTER |
| 20653404046680 | CONMED GOLDLINE FOOT CONTROLLED WITH NEEDLE ELECTRODE SAFETY HOLSTER AND 10 FOOT (3M) CABLE, ELE |
| 30845854041752 | 3DHD CAMERA CONTROLLER |
| 30845854038820 | 3DHD DUAL CHANNEL CAMERA HEAD |
| 30845854038813 | 3DHD SINGLE CHANNEL CAMERA HEAD |
| 30845854038752 | LAPAROSCOPE 5.5MM 45 DEGREE |
| 30845854024861 | 3DHD 2D CAMERA HEAD |
| 30845854024847 | LAPAROSCOPE 5.5MM 30 DEGREE |
| 20845854013271 | SMALL JOINT ELECTRODE BASIC KIT; 90 DEGREE TIP |
| 30653405050272 | CONMED SCOPE SAVER BITE BLOCK |
| 10653405031772 | ELECTROSURGICAL DISPERSIVE PATIENT PLATE |
| 10845854050378 | CrossFT Knotless 4.0/4.75 Broaching Punch, Disposable |
| 20845854850364 | CrossFT Knotless 4.0/4.75 Broaching Punch |
| 20845854050351 | CrossFT Knotless DT 4.75 Tap |
| 20845854050344 | CrossFT Knotless DT 5.5 Tap |
| 20845854050337 | CrossFT Knotless DT 4.0 Tap |
| 20653405050572 | CONMED BLUE BULLET DISPOSABLE CLEANING BRUSH |
| 30845854902671 | Shoulder Accessories Insert Tray #1 |
| 30845854902664 | Shoulder Instability Insert Tray |
| 10653405986676 | American Dilator, 57 F |
| 40653405050439 | Reusable G/D/C Cleaning Brush |
| 30653405056007 | FS SAFETY CABLE IEC |
| 30653405050449 | Reusable Bronc Cleaning Brush |
| 10653405050421 | Combo Cleaning Brush |
| 10653405050414 | Double End Cleaning Brush |
Trademark Results [CONMED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CONMED 87743956 not registered Live/Pending |
ConMed Corporation 2018-01-04 |
 CONMED 87551457 5467478 Live/Registered |
ConMed Corporation 2017-08-01 |
 CONMED 87013011 5304308 Live/Registered |
ConMed Corporation 2016-04-25 |
 CONMED 75292291 2213939 Live/Registered |
ConMed Corporation 1997-05-15 |
 CONMED 73000298 1004240 Live/Registered |
CONSOLIDATED MEDICAL EQUIPMENT, INC. 1973-09-06 |
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