PRIMAEVA MEDICAL RENESIS SYSTEM
PRIMAEVA MEDICAL, INC.
Primary Products Company/Lehman International Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2134758 | 3002843636 | Primary Products Company/Lehman International Inc | 1 | Y | 2026-01-01 | 4444 Centerville Road Suite 120 White Bear Lk MN US 55127 |
| 3005616800 | 3005616800 | PRIMA CARE MEDICAL SUPPLIES, INC. | 1 | N | 2026-01-01 | 239 6th Ave Paterson NJ US 07524 |
| 3011648981 | 3011648981 | Primark US Corp | 1 | Y | 2026-01-01 | 2485 Commerce Center Blvd Bethlehem PA US 18015 |
| 3012166707 | 3012166707 | Primal Life Organics | 1 | Y | 2026-01-01 | 7376 Whipple Ave Nw North Canton OH US 44720 |
| 3030229208 | 3030229208 | Primark US Corp | 1 | Y | 2026-01-01 | 1511 Zoo Pkwy Building 200 JAX FL US 32218 |
| 0 | 0 | PRIMA USA TRAVEL INC | 5 | Y | 2020-04-25 | 2557 Yates Ave. Commerce CA US 90040 |
| 3009307663 | 3009307663 | Primasil Silicones Limited | 1 | N | 2020-04-25 | Kington Road Industrial Estate Weobley Herefordshire, County of GB HR48QU |
| 3011208747 | 3011208747 | PRIMA TEMP, INC. | 1 | N | 2020-04-25 | 3100 Arapahoe Ave. Suite 500 Boulder CO US 80303 |
| 3016631333 | 3016631333 | PRIMARY CARE WALK IN CLINIC PLLC | 1 | Y | 2020-04-25 | 6329 State Road 54 New Port Richey FL US 34653 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 138873 | 1232194101 | K193259 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | DXQ | 2020-07-02 |
| 138873 | 1786376937 | K082208 | DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER | NAC | 2008-12-01 |
| 130841 | 1281707662 | ||||
| 176166 | 1656271371 | ||||
| 130841 | 1681345655 | ||||
| 248461 | 1896256509 |
Product Codes Associated With Registrations#
PMN#
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
PRIMARY CARE SOLUTIONS, INC.
PRIMAEVA MEDICAL SYSTEM
PRIMAEVA MEDICAL, INC.
FINESSE SYSTEM
PRIMAEVA MEDICAL, INC.
SPECTRAPULSE
PRIMARY TECHNOLOGY, LLC.
PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
PRIMARY CARE SOLUTIONS, INC.
SPECTRAPULSE
PRIMARY TECHNOLOGY, LLC.
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
PRIMARY CARE SOLUTIONS, INC.
PRIMA VOLUMN VENTILATORSS
PRIMA, INC.
PRIMA VENTILATOR HOSES
PRIMA, INC.
PRIMA PEDIATRIC GAS SAMPLING CIRCUITS
PRIMA, INC.
PRIMA PEDIATRIC ANESTHESIA CIRCUITS
PRIMA, INC.
PRIMA MAPLESON D CIRCUIT
PRIMA, INC.
PRIMA HYUPERINFLATION SYSTEM
PRIMA, INC.
PRIMA GUEDEL AIRWAYS
PRIMA, INC.
PRIMA FILTER
PRIMA, INC.
PRIMA CUSTOM ANESTESIA CIRCUIT
PRIMA, INC.
PRIMA COAXIAL CIRCUITS
PRIMA, INC.
PRIMA BREATHING BAGS
PRIMA, INC.
PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
PRIMA, INC.
PRIMA ADULT GAS SAMPLING CIRCUITS
PRIMA, INC.
PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS
PRIMA, INC.
PRIMA, INC. CORRUGATED TUBING
PRIMA, INC.
PRIMA, INC. VENTILATOR HOSES
PRIMA, INC.
PRIMA, INC. ADULT ANESTHESIA CIRCUIT
PRIMA, INC.
PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
PRIMA, INC.
PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS
PRIMA, INC.
GUDID#
PrimaPro - PrimaPro GentleGuard Blue Synthetic Powder Free Examination Glove Small, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2020-09-09
PrimaPro - PrimaPro GentleGuard Blue Synthetic Powder Free Examination Glove Medium, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2020-09-09
PrimaPro - PrimaPro GentleGuard Blue Synthetic Powder Free Examination Glove Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2020-09-09
PrimaPro - PrimaPro GentleGuard Blue Synthetic Powder Free Examination Glove X-Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2020-09-09
PrimaPro - PrimaPro GentleGuard Bluple Powder Free Examination Glove Small, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2020-12-30
PrimaPro - PrimaPro GentleGuard Bluple Powder Free Examination Glove Medium, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2020-12-30
PrimaPro - PrimaPro GentleGuard Bluple Synthetic Powder Free Examination Glove Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2020-12-30
PrimaPro - PrimaPro GentleGuard Bluple Powder Free Examination Glove X-Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use.
2020-12-30
PrimaPro - PrimaPro GentleGuard Powder Free Examination Glove X-Small, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2026-04-28
PrimaPro - PrimaPro GentleGuard Comfort Fit Blu 2 Nitrile Powder Free Examination Glove 2X-Large, 180 Gloves/Box, 10 Bag/Case, 1,800 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2025-02-12
PrimaPro - PrimaPro GentleGuard Comfort Fit Blu 2 Nitrile Powder Free Examination Glove X-Small, 200 Gloves/Box, 10 Bag/Case, 2,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2025-02-12
PrimaPro - PrimaPro GentleGuard Comfort Fit Bagged Nitrile Powder Free Examination Glove 2X-Large, 180 Gloves/Bag, 10 Bag/Case, 1,800 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2025-02-12
PrimaPro - PrimaPro GentleGuard Comfort Fit Blu 2 Nitrile Powder Free Examination Glove 2X-Large, 180 Gloves/Box, 10 Bag/Case, 1,800 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2025-02-12
PrimaPro - PrimaPro GentleGuard Comfort Fit Blu 2 Nitrile Powder Free Examination Glove X-Small, 200 Gloves/Box, 10 Bag/Case, 2,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2025-02-12
PrimaPro - PrimaPro GentleGuard Comfort Fit Bagged Nitrile Powder Free Examination Glove 2X-Large, 180 Gloves/Bag, 10 Bag/Case, 1,800 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2025-02-12
PrimaPro - PrimaPro GentleGuard Latex Powder Free Examination Glove Small, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2020-09-09
PrimaPro - PrimaPro GentleGuard Latex Powder Free Examination Glove Medium, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2020-09-09
PrimaPro - PrimaPro GentleGuard Latex Powder Free Examination Glove Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2020-09-09
PrimaPro - PrimaPro GentleGuard Latex Powder Free Examination Glove X-Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2020-09-09
PrimaPro - PrimaPro GentleWare ASTM Level 2 Face Mask, White, 3 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use
2020-09-18
PrimaPro - PrimaPro GentleWare ASTM Level 2 Face Mask, White, 3 Ply with Ear Loops, Latex Free, 50 Masks/Bag, 20 Bags/Case, 1,000 Masks/Case, Single Use
2020-09-18
PrimaPro - Prima Pro GentleWare ASTM Level 2 Face Mask, Blue, 3 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use
2020-09-18
PrimaPro - PrimaPro GentleWare ASTM Level 3 Face Mask, Blue, 4 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use
2020-09-18
PrimaPro - PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove 3X-Large, 90 Gloves/Box, 10 Box/Case, 900 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2024-12-17
PrimaPro - PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove 3X-Large, 90 Gloves/Box, 10 Box/Case, 900 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2024-12-17
PrimaPro - PrimaPro Gentle Guard Comfort Fit Ultra Shield Nitrile Powder Free Examination Glove, XX-Large, 90 Gloves/Box, 10 Box/Case, 900 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2024-07-01
PrimaPro - PrimaPro Gentle Guard Comfort Fit Ultra Shield Nitrile Powder Free Examination Glove, X-Small, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2024-07-01
PrimaPro - PrimaPro Gentle Guard Comfort Fit Ultra Shield Nitrile Powder Free Examination Glove, XX-Large, 90 Gloves/Box, 10 Box/Case, 900 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2024-07-01
PrimaPro - PrimaPro Gentle Guard Comfort Fit Ultra Shield Nitrile Powder Free Examination Glove, X-Small, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
2024-07-01
PrimaPro - PrimaPro Gentle Guard Comfort Fit Ultra Shield Nitrile Powder Free Examination Glove Small, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single-Use
2020-09-09
PrimaPro - PrimaPro Gentle Guard Comfort Fit Ultra Shield Nitrile Powder Free Examination Glove Medium, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single-Use
2020-09-09
PrimaPro - PrimaPro Gentle Guard Comfort Fit Ultra Shield Nitrile Powder Free Examination Glove Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single-Use
2020-09-09
PrimaPro - PrimaPro Gentle Guard Comfort Fit Ultra Shield Nitrile Powder Free Examination Glove X-Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single-Use
2020-09-09
Carbide rotary dental burs - CFNFLAG23FG725c
2023-02-08
Diamond roatry dental burs - DFM2280C615c
2023-02-08
Carbide rotary dental burs - CFNNEE009FZ775c
2023-02-08
Carbide rotary dental burs - CFNNEE010FZ775c
2023-02-08
Carbide rotary dental burs - CFNNEEG09FZ725c
2023-02-08
Carbide rotary dental burs - CFNNEEG10FZ725c
2023-02-08
Carbide rotary dental burs - CFNNEEG12FZ725c
2023-02-08