| Primary Device ID | 00810077212097 |
| NIH Device Record Key | a31eed4f-abbe-4797-8e11-94ac69c6401d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avaline Medical NJ LLC |
| Version Model Number | vk1cbp |
| Catalog Number | vk1cbp |
| Company DUNS | 079767953 |
| Company Name | Avaline Medical NJ Limited Liability Company |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(732)813-7799 |
| jstein@avalinemedical.com | |
| Phone | +1(732)813-7799 |
| jstein@avalinemedical.com | |
| Phone | +1(732)813-7799 |
| jstein@avalinemedical.com | |
| Phone | +1(732)813-7799 |
| jstein@avalinemedical.com | |
| Phone | +1(732)813-7799 |
| jstein@avalinemedical.com | |
| Phone | +1(732)813-7799 |
| jstein@avalinemedical.com | |
| Phone | +1(732)813-7799 |
| jstein@avalinemedical.com | |
| Phone | +1(732)813-7799 |
| jstein@avalinemedical.com | |
| Phone | +1(732)813-7799 |
| jstein@avalinemedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810077212097 [Primary] |
| FNP | URINAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-25 |
| Device Publish Date | 2021-10-15 |
| 00850025452632 | 100 Vakly Disposable Graduated Plastic Medicine Cups, 1 OZ |
| 00850025452618 | 25 Vakly 4oz Specimen Cups with Screw On Lids |
| 00850025452496 | 5 Pack of Vakly 4oz Sterile Specimen Cups Individually Bagged with Screw On Lids |
| 00810077210147 | Pill Crusher Pouches |
| 00810077210116 | 200 Dental Cotton Rolls |
| 00810077210451 | (5000) Paper Medicine Cups, 3/4 oz, (Disposable Souffle Cups) (5000) |
| 00810077210819 | 10 Pack Mesh High Waist Knit Underwear for Postpartum and Incontinence Size (XL-2XL) |
| 00810077210826 | 10 Pack Mesh High Waist Knit Underwear for Postpartum and Incontinence Size (Medium/Large) |
| 00810077210949 | 2000 Non-Sterile Medium Cotton Balls - 2000 Bag |
| 00810077210925 | Disposable Tissue/Poly Pillowcases 21" x 30", White (50 Pack) |
| 00810077210901 | Dental Bibs/Tattoo Bibs – 3 Layers of Protection - 13'' x 18" Black 250 |
| 00810077210871 | Dental Bibs/Tattoo Bibs – 3 Layers of Protection - 13'' x 18" Pink 250 |
| 00810077210802 | Vakly 2-Ply Drape Sheet - 40"x 48", White (50 Pack) |
| 00810077210789 | 2 Pack 21''x125' Standard White Crepe Exam Table Paper 2 Rolls |
| 00810077210765 | 18''x125’ Standard White Crepe Exam Table Paper Pack Of 2 |
| 00810077210741 | 8''x225’ Smooth Headrest Paper / Exam Table Paper 2 Pack |
| 00810077210727 | Vakly Delux Disposable Polymer Underpads Maximum Absorbency (Chux) 30X36 20 Pack |
| 00810077210703 | Vakly Tubular Stockinette 4"X 25 Yards |
| 00810077210697 | Vakly Tubular Stockinette 3"X 25 Yards |
| 00810077210680 | Vakly Tubular Stockinette 2" X 25 Yards |
| 00810077210673 | 40 Extra Large Super-Absorbent Contoured Pad Liners - 7"X14" |
| 00810077212158 | Knit Heel And Elbow Protector 2 PAIR |
| 00810077212127 | Triangular Intake/Output x5 |
| 00810077212097 | Stackable Contour Bedpan |
| 00810077212080 | Contour Bariatric Bedpan |
| 00810077212073 | Fracture Bed Pan |
| 00810077212042 | 1 Specimen Collector Pan |
| 00810077211991 | Paper Surgical Tape - 1 inch x6 |
| 00850025452939 | 25 Specimen Cups with Leak Proof Screw on Lids - 3.5 oz |
| 00810077212141 | 17''x24'' Underpads x300 |
| 00810077212103 | Paper Surgical Tape - 2 inch x4 |
| 00810077212134 | Disposable Toothbrushes 24 |
| 00810077211687 | Male Urinal With Cover x2 |
| 00810077211649 | Calculi Strainer / Kidney Stone Collector (2 Pack) |
| 00810077211984 | Paper Surgical Tape - 3 inch x3 |
| 00810077211601 | Plastic Medicine Cups, 2 OZ x160 |
| 00810077211977 | 10 Sterile Stool Specimen Cup |
| 00810077210185 | Foam Heel Protectors |
| 00810077212424 | Maximum Absorbency Maternity Pads 42 |
| 00810077212493 | Split Drain Sponge 4x4 6 Ply 100 plus Tape |
| 00810077212455 | Combine Abdominal Pads 8x10 20 plus Tape |
| 00810077212431 | Combine Abdominal Pads 5x9 40 plus Tape |
| 00810077212479 | Medium Cotton Balls 500 |
| 00810077212462 | Multi-Trauma Dressing 10’’x30’’ x2 plus Tape |
| 00810077211861 | Washable Underpads 34"x36" x1 |
| 00810077211854 | Washable Underpads 23"x36" x1 |
| 00810077211816 | Washable Underpads 36"x54" x1 |
| 00810077211243 | Adhesive Moleskin Roll |
| 00810077212486 | Split Drain Sponge 2x2 6 Ply 140 plus Tape |
| 00810077212509 | Washable Underpads 36"x72" x2 |