| Primary Device ID | 00850046230004 |
| NIH Device Record Key | 12ead062-66b3-4241-8c8c-1bc79c7b5b38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Future Generation Medical |
| Version Model Number | GB18115 |
| Company DUNS | 079251688 |
| Company Name | Global International L. L. C. |
| Device Count | 1000 |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com | |
| Phone | (888) 291-7638 |
| info@fgmmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850046230004 [Unit of Use] |
| GS1 | 10850046230001 [Primary] |
| GAA | Needle, Aspiration And Injection, Disposable |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
[00850046230004]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-21 |
| Device Publish Date | 2022-11-13 |
| 00850046230288 | Toe Warmer(10h) |
| 00850046230271 | Gel Beads |
| 00850046230264 | Hot & Cold Gel Therapy Slippers |
| 00850046230257 | Hot & Cold Treatment Sock /Large & XL - - Pad included |
| 00850046230240 | Hot & Cold Treatment Sock / Small & Medium - Pad included |
| 00850046230233 | Foot Warmer(10h) / Small |
| 00850046230226 | Foot Warmer(10h) / Large |
| 00850046230134 | FGM Luer Lock Prefilled Syring 3ml Luer Lock |
| 00850046230127 | FGM Luer Lock Prefilled Syring 5ml Luer Lock |
| 00850046230110 | FGM Luer Lock Prefilled Syring 10ml Luer Lock |
| 00850046230103 | Infant Heel Warmers - W/O Metal Disc |
| 00850046230097 | Infant Heel Warmers - With Disc |
| 00850046230080 | Safety Syringes 1ml with 25G x 1in |
| 00850046230073 | Safety Syringes 1ml with 25G x 5/8in |
| 00850046230066 | Safety Syringes 1ml with 27G x 1/2in |
| 00850046230059 | Safety Syringes 1ml with 30G x 1/2in |
| 00850046230042 | Instant Hot Compress, Large |
| 00850046230035 | Instant Hot Compress, Large |
| 00850046230028 | FGM Hypodermic BLUNT NEEDLE FILTER 18G x 1 1/2 |
| 00850046230011 | FGM BLUNT WITH FILTER NEEDLE 18G x 1" |
| 00850046230004 | FGM HYPODERMIC BLUNT NEEDLE, 18G x 1 1/2" |
| 00850046230301 | Small Towel Drape w. Adhesive Strip 17" x 11 |
| 00850046230332 | Medium Drape w. Aperature 31" x 51" |
| 00850046230325 | Ophthalmic Aperture Drape, 40x40cm, 6cm dia. Aperture |
| 00850046230318 | Large PE Drape 17" x 23" |
| 00850046230219 | FGM Spinal Needle 18G Quincke Tip |
| 00850046230202 | FGM Spinal Needle 19G Quincke Tip |
| 00850046230196 | FGM Spinal Needle 20G Quincke Tip |
| 00850046230189 | FGM Spinal Needle 22G Quincke Tip |
| 00850046230172 | FGM Spinal Needle 25G Quincke Tip |
| 00850046230165 | FGM Spinal Needle 26G Quincke Tip |
| 00850046230158 | FGM Spinal Needle 27G Quincke Tip |
| 00850046230141 | FGM Spinal Needle 29G Quincke Tip |