FDA.reportPublic FDA data

COVER FOR 6946, 6947 TEMPUR PILLOW

Primary DI
10842430110877
Brand
COVER FOR 6946, 6947 TEMPUR PILLOW
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
6947-50
Catalog number
6947-50
Published
2019-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842430110877PrimaryGS10
00842430110870Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084243011087710842430110877
00842430110870008424301108708424301108700842430110870

GMDN Terms#

Term, Definition table
TermDefinition
Basic pillowcase, single-useA protective envelope for a pillow typically made of a thin-textile or reinforced-paper material that creates a physical barrier to soiling and cross-contamination. It does not include antimicrobial or dust mite barrier/prevention properties. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags#

DUNS number
084527241
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842430117312ADANTE DURABLE BODY STRAP, NO HOOK6895-13656895-13652026-04-17
00842430116667ADANTE PELVIC CENTER POSTLESS PAD6895-13066895-13062025-07-04
00842430116735ADANTE ADAPTER, MAI CLARK SOCKET6895-21906895-21902026-03-31
00842430116766 WELL LEG SUPPORT, SHORT5855-838S5855-838S2026-03-31
00842430116742PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
00842430116759PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
10842430116749PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
10842430116756PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
00842430101717TABLE, INSITE684468442020-09-09
00842430107450INSITE TABLE, 230V6844i6844i2020-09-09
00842430107467TABLE, ProFx, 230 VOLT6850i6850i2020-09-09
00842430112102TABLE, ProFx685068502020-09-09
00842430114601TABLE, INSITE, 100V6844J6844J2020-09-08
00842430100017Allegro Imaging Table 120V, 60HZ680068002016-09-13
00842430100024Allegro Imaging Table 220-230V, 50/60HZ6800I6800I2016-09-15
00842430109188PRONECONNECT PROTECTIVE HELMETPC501FHPC501FH2025-08-29
00842430109195PRONECONNECT ADJUSTABLE HELMETPC502AHPC502AH2025-08-29
00842430109201PRONECONNECT COMBO PACK 4L, 3M, 3SPC-COMBOPC-COMBO2025-08-29
00842430109218PRONECONNECT LOW PROFILE MIRRORPC520MPC520M2025-08-29
00842430109225PRONECONNECT ADJUSTABLE MIRRORPC590MPC590M2025-08-29

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