Future Generation Medical

GUDID 00850046230103

Infant Heel Warmers - W/O Metal Disc

Global International L. L. C.

Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use
Primary Device ID00850046230103
NIH Device Record Key263013d1-076a-4c5c-bbf5-791566f152a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuture Generation Medical
Version Model NumberFG-IHW-5003A
Company DUNS079251688
Company NameGlobal International L. L. C.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com
Phone(888) 291-7638
Emailinfo@fgmmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850046230103 [Unit of Use]
GS110850046230100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MPOInfant Heel Warmer (Chemical Heat Pack)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

[00850046230103]

Dry Heat Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-21
Device Publish Date2022-11-13

On-Brand Devices [Future Generation Medical ]

00850046230288Toe Warmer(10h)
00850046230271Gel Beads
00850046230264Hot & Cold Gel Therapy Slippers
00850046230257Hot & Cold Treatment Sock /Large & XL - - Pad included
00850046230240Hot & Cold Treatment Sock / Small & Medium - Pad included
00850046230233Foot Warmer(10h) / Small
00850046230226Foot Warmer(10h) / Large
00850046230134FGM Luer Lock Prefilled Syring 3ml Luer Lock
00850046230127FGM Luer Lock Prefilled Syring 5ml Luer Lock
00850046230110FGM Luer Lock Prefilled Syring 10ml Luer Lock
00850046230103Infant Heel Warmers - W/O Metal Disc
00850046230097Infant Heel Warmers - With Disc
00850046230080Safety Syringes 1ml with 25G x 1in
00850046230073Safety Syringes 1ml with 25G x 5/8in
00850046230066Safety Syringes 1ml with 27G x 1/2in
00850046230059Safety Syringes 1ml with 30G x 1/2in
00850046230042Instant Hot Compress, Large
00850046230035Instant Hot Compress, Large
00850046230028FGM Hypodermic BLUNT NEEDLE FILTER 18G x 1 1/2
00850046230011FGM BLUNT WITH FILTER NEEDLE 18G x 1"
00850046230004FGM HYPODERMIC BLUNT NEEDLE, 18G x 1 1/2"
00850046230301Small Towel Drape w. Adhesive Strip 17" x 11
00850046230332Medium Drape w. Aperature 31" x 51"
00850046230325Ophthalmic Aperture Drape, 40x40cm, 6cm dia. Aperture
00850046230318Large PE Drape 17" x 23"
00850046230219FGM Spinal Needle 18G Quincke Tip
00850046230202FGM Spinal Needle 19G Quincke Tip
00850046230196FGM Spinal Needle 20G Quincke Tip
00850046230189FGM Spinal Needle 22G Quincke Tip
00850046230172FGM Spinal Needle 25G Quincke Tip
00850046230165FGM Spinal Needle 26G Quincke Tip
00850046230158FGM Spinal Needle 27G Quincke Tip
00850046230141FGM Spinal Needle 29G Quincke Tip
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