Thermoflect

GUDID 10612899004129

THERMOFLECT GOWN KIT B, 25 EA TS THERMOFLECT GOWN KIT B, GOWN, CAP, PSFW,2 BEL BG, 25EA NW

Encompass Group, L.L.C.

Hypothermia-prevention whole-body suit

• Primary Device ID: 10612899004129
• NIH Device Record Key: d33e7f28-4371-49cd-b8fa-999d20f5aa52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermoflect
• Version Model Number: 5000-810
• Company DUNS: 121788819
• Company Name: Encompass Group, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612899004122 [Primary]
GS1	10612899004129 [Package]; Contains: 00612899004122; Package: CA [25 Units]; In Commercial Distribution

FDA Product Code

• FME: Gown, Examination

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-05
• Device Publish Date: 2022-11-01

On-Brand Devices [Thermoflect]

• 40612899510409: THERMOFLECT BLANKET, M, 50EA TS THERMOFLECT BLANKET, 48" X 48",
• 40612899510256: THERMOFLECT PAPOOSE, S, 50EA TS THERMOFLECT PAPOOSE, UP TO 10 LB
• 30612899510204: THERMOFLECT BLANKET, S, 60EA TS THERMOFLECT BLANKET, 36" X 40",
• 40612899512359: THERMOFLECT LEGGINGS, 100EA TS THERMOFLECT LEGGINGS, ADJUSTABLE
• 40612899511529: THERMOFLECT BOOTIES, 50EA TS THERMOFLECT BOOTIES, SILVER, 10/BG, 5
• 40612899511253: THERMOFLECT CAP, NEO, 100EA TS THERMOFLECT BOUFFANT, STOCKINETT
• 30612899511201: THERMOFLECT CAP, INFANT, 100EA TS THERMOFLECT BOUFFANT, STOCKINET
• 40612899511154: THERMOFLECT CAP, XS, 50EA TS THERMOFLECT BOUFFANT CAP, ELASTI
• 40612899511109: THERMOFLECT CAP, UNIV, 100EA TS THERMOFLECT BOUFFANT CAP, ELASTI
• 40612899510706: THERMOFLECT BLANKET, L, 25EA TS THERMOFLECT BLANKET, 48" X 84", S
• 10612899520704: THERMOFLECT LG BLKT KIT, 24EA TS LG BLKT & ADULT CAP KIT, SILVER,
• 10612899520407: THERMOFLECT MD BLKT KIT, 20EA TS THERMOFLECT KIT, MED BLKT, ADULT
• 10612899002682: THERMOFLECT COCOON, PED, 10EA TS THERMOFLECT COCOON, PEDIATRIC, S
• 10612899001050: THERMOFLECT COCOON, UNIV, 10EA TS THERMOFLECT COCOON, ADULT, SILVER, 1/
• 10612899540108: THERMOFLECT ROLL, 100M, 1EA TS THERMOFLECT ROLL MATERIAL, SILVER
• 50612899286899: PATIENT TRANSFER KIT D, 25EA TS PT TRANS KIT, GOWN TF BLKT ST SH
• 10612899004402: PATIENT TRANSFER KIT C, 25EA TS PT TRANS KIT, GOWN, TF BLKT, ST
• 10612899004303: THERMOFLECT KIT 3, UNIV, 25EA TS TF KIT, BLKT, CAP, FOOTWEAR, BAG,
• 40612899514506: THERMOFLECT JACKET, XL, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/
• 40612899514452: THERMOFLECT JACKET, L, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/CU
• 40612899514407: THERMOFLECT JACKET, L, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/
• 40612899514353: THERMOFLECT JACKET, M, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/CU
• 40612899514308: THERMOFLECT JACKET, M, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/
• 40612899510515: THERMOFLECT MITT, UNIV, 50EA TS THERMOFLECT OXIMETER MITT, SILVER
• 40612899004274: THERMOFLECT JACKET, 2X, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/
• 40612899004175: THERMOFLECT IV SLEEVE, 100EA TS THERMOFLECT IV SLEEVE, SILVER, 20/B
• 40612899004113: THERMOFLECT ACCESS GOWN, 25 EA TS THERMOFLCT GOWN, STANDARD, SILVER
• 40612899004014: THERMOFLECT IV GOWN, 25EA TS THERMOFLECT IV GOWN, UNIV, SILVER/
• 40612899003949: THERMOFLECT JACKET, S, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/CU
• 40612899003932: THERMOFLECT JACKET, S, 25EA TS THERMOFLECT JACKET, KNIT COLLAR
• 40612899003925: THERMOFLECT JACKET, XS, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/CU
• 40612899003840: THERMOFLECT JACKET, XL, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/CU
• 40612899003819: THERMOFLECT GOWN, S, 25EA TS THERMOFLECT PATIENT IV GOWN, SIL
• 40612899003802: THERMOFLECT PED GOWN, L, 25EA TS THERMOFLECT PEDIATRIC IV GOWN, S
• 40612899003796: THERMOFLECT PED GOWN, M, 25EA TS THERMOFLECT PEDIATRIC IV GOWN, S
• 40612899003185: THERMOFLECT GOWN, XL, 25EA TS THERMOFLECT GOWN, STANDARD, SILV
• 10612899005904: THERMOFLECT GOWN KIT, 25 EA TS THERMOFLECT GOWN KIT, GOWN,CAP,2
• 10612899004372: THERMOFLECT BLANKET, L, 25EA TS THERMOFLECT BLANKET, 48" X 84",
• 10612899004297: THERMOFLECT GOWN KIT D, 25 EA TS THERMOFLECT GOWN KIT D, GOWN, PSFW, 25
• 10612899004280: THERMOFLECT GOWN KIT C, 25 EA TS THERMOFLECT GOWN KIT C, GOWN, CAP,
• 10612899004211: THERMOFLECT PEDS GWN KIT 25 EA TS THERMOFLECT PEDIATRIC GOWN KIT F, GO
• 10612899004181: THERMOFLECT GOWN KIT E, 25 EA TS THERMOFLECT GOWN KIT E, GOWN, CAP, 25 EA
• 10612899004129: THERMOFLECT GOWN KIT B, 25 EA TS THERMOFLECT GOWN KIT B, GOWN, CA
• 10612899004105: THERMOFLECT GOWN KIT A, 25 EA TS THERMOFLECT GOWN KIT A, GOWN, CA
• 40612899003918: THERMOFLECT JACKET, XS, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/
• 10612899004389: PATIENT TRANSFER KIT, 25EA KIT INCLUDES GOWN BLANKET SHEET PILLOWC