FDA.report

Encompass

Primary DI
10612899000381
Brand
Encompass
Company
Encompass Group, L.L.C.
Model
46150-035
Device description
INFANT SHIRT, NB, 300EA TS INFANT SHIRT, LONG SLV, PRINT, PET, 25/BG, 12 BG/CS NW
Published
2022-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMEGown, Examination

Product Code Classifications

CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10612899000381PrimaryGS10
30612899000385Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1061289900038110612899000381
3061289900038530612899000385

GMDN Terms

TermDefinition
Patient gown, single-useA non-sterile garment made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and may be closed by ties at the back/side of the garment. This is a single-use garment.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-284-4540compliance@encompassgroup.net

Regulatory Flags

DUNS number
121788819
Device count
300
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00612899045484EncompassVA550-252023-06-22
00612899101104EncompassVA550-25XB2023-06-22
20612899002726EncompassTP1002023-06-22
20612899004713EncompassG-P91532023-06-22
20612899004720EncompassG-P9163A2023-06-22
20612899005574EncompassG-P91642023-06-22
20612899005581EncompassG-P9165A2023-06-22
20612899005598EncompassG-P91662023-06-22
20612899005604EncompassG-P91512023-06-22
20612899005611EncompassG-P91522023-06-22
20612899005628EncompassG-P91542023-06-22
20612899005635EncompassG-P91552023-06-22
20612899005642EncompassG-P91562023-06-22
20612899005659EncompassG-P9161A2023-06-22
20612899005666EncompassG-P9162A2023-06-22
20612899005673EncompassG-P91642023-06-22
20612899005680EncompassP9165A2023-06-22
20612899005697EncompassP91662023-06-22
20612899005826EncompassG-P91502023-06-22
20612899005864EncompassG-P91602023-06-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10842942015448PRIMEDpriMED Medical Products IncFME2026-02-10
00810180842457Exam Capes, Tissue/Poly/Tissue 3-ply, Lavender, UniversalDynarex CorporationFME2026-01-05
26975803530888GSOGroup Supply Organization Medical Technology(Shanghai) LtdFME2025-11-30
10842942017527PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
10842942017534PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
10842942007825PRIMEDpriMED Medical Products IncFME2025-07-21
10842942008204PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009348PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009355PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009362PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009379PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009553PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009560PRIMEDpriMED Medical Products IncFME2025-07-21
10842942013925PRIMEDpriMED Medical Products IncFME2025-07-21
10842942014472PRIMEDpriMED Medical Products IncFME2025-07-21
10842942014489PRIMEDpriMED Medical Products IncFME2025-07-21
10842942016087PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524427PRIMEDpriMED Medical Products IncFME2025-07-21
00840456201565JMUJMU DENTAL, INCFME2025-07-15
00840456201572JMUJMU DENTAL, INCFME2025-07-15
00840456201589JMUJMU DENTAL, INCFME2025-07-15
00840456201596JMUJMU DENTAL, INCFME2025-07-15
00840456201602JMUJMU DENTAL, INCFME2025-07-15
00840456201619JMUJMU DENTAL, INCFME2025-07-15
00840456201626JMUJMU DENTAL, INCFME2025-07-15
00840456201633JMUJMU DENTAL, INCFME2025-07-15
00840456201640JMUJMU DENTAL, INCFME2025-07-15
00840456201657JMUJMU DENTAL, INCFME2025-07-15
00840456201664JMUJMU DENTAL, INCFME2025-07-15
00840456201671JMUJMU DENTAL, INCFME2025-07-15