ProCure™ PCSS735
GUDID 30840330703650
ProCure Safe TB Tuberculin Safety Syringe 1ml 27g x 1/2" - 100ea/bx 8bx/cs
Twin Med, LLC
Insulin syringe/needle, safety| Primary Device ID | 30840330703650 |
| NIH Device Record Key | ce2e31d5-600b-439a-b558-a73371f3daa7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProCure™ |
| Version Model Number | PCSS735 |
| Catalog Number | PCSS735 |
| Company DUNS | 107071289 |
| Company Name | Twin Med, LLC |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com | |
| Phone | 612-819-1635 |
| sanderson@twinmed.com |
Device Dimensions
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
| Length | 4.5 Inch |
| Needle Gauge | 27 Gauge |
| Outer Diameter | 0.5 Inch |
| Total Volume | 1 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry, Keep away from Direct Sunlight |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10840330703656 [Primary] |
| GS1 | 30840330703650 [Package] Contains: 10840330703656 Package: Box [100 Units] In Commercial Distribution |
| GS1 | 50840330703654 [Package] Package: Case [8 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150758
FDA Product Code
| MEG | Syringe, Antistick |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-12 |
| Device Publish Date | 2023-10-04 |
On-Brand Devices [ProCure™]
| 30840330703681 | ProCure Safe Insulin Safety Syringe 1/2cc 31g x 5/16" 100ea/bx 8bx/cs |
| 30840330703674 | ProCure Safe Insulin Safety Syringe 1cc 31g x 5/16" 100ea/bx 8bx/cs |
| 30840330703667 | ProCure Safe TB Tuberculin Safety Syringe 1ml 28g x 1/2" - 100ea/bx 8bx/cs |
| 30840330703650 | ProCure Safe TB Tuberculin Safety Syringe 1ml 27g x 1/2" - 100ea/bx 8bx/cs |
| 30840330703643 | ProCure Safe TB Tuberculin Safety Syringe 1ml 25g x 5/8" - 100ea/bx 8bx/cs |
| 30840330703636 | ProCure™ Safe Insulin Safety Syringe 1/2cc 29g x 1/2" 100ea/bx 8bx/cs |
| 30840330703629 | ProCureSafe Insulin Safety Syringe 1cc 29g x 1/2" 100ea/bx 8bx/cs |
| 30840330703612 | Hot Pack- Hot Pack Instant 6"x 9" - 24ea/cs |
| 30840330703605 | Cold Pack- Ice Pack Instant 6"x 9" - 24ea/cs |
Trademark Results [ProCure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROCURE 98567228 not registered Live/Pending |
ProcureNetworks LLC 2024-05-24 |
 PROCURE 98164332 not registered Live/Pending |
ProFoot, Inc. 2023-09-05 |
 PROCURE 97680041 not registered Live/Pending |
ProcureNetworks LLC 2022-11-16 |
 PROCURE 97610720 not registered Live/Pending |
ProCure Systems, LLC 2022-09-28 |
 PROCURE 97610699 not registered Live/Pending |
ProCure Systems, LLC 2022-09-28 |
 PROCURE 90709092 not registered Live/Pending |
SprintRay, Inc. 2021-05-13 |
 PROCURE 90604224 not registered Live/Pending |
ProcureNetworks LLC 2021-03-25 |
 PROCURE 88577566 not registered Live/Pending |
Twin Med, LLC 2019-08-13 |
 PROCURE 88527984 not registered Live/Pending |
Lloyd Fisher 2019-07-22 |
 PROCURE 88438807 not registered Live/Pending |
Twin Med, LLC 2019-05-20 |
 PROCURE 87675000 not registered Dead/Abandoned |
Ralco Nutrition, Inc. 2017-11-07 |
 PROCURE 87089631 5137415 Live/Registered |
ScanMed, LLC 2016-06-30 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.